ClinicalTrials.gg
WithdrawnNCT03361774Updated Feb 15, 2019

A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity

A Phase 2 interventional study of Dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride). and Dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride). in Dentin Sensitivity, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Cancelled before Active

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Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 28 studies in Dentin Sensitivity by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Dentin Sensitivity · GlaxoSmithKline.

Enrollment
28th of 28
0 · median 164
Started
2018
the only one that year
Phase 2
6 of 28
none open now
Registered
27th of 28
by date

Among the 28 studies in Dentin Sensitivity by GlaxoSmithKline, this one is the 28th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 2, and was the 27th registered.

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

Browse Dentin Sensitivity studies →

Open to participants now

None of the 28 studies in Dentin Sensitivity by GlaxoSmithKline is open now. The open studies under Dentin Sensitivity, anywhere →

Who these studies take

Of the 18 Dentin Sensitivity studies recruiting now, 6 (33%) set no upper age limit and 11 (61%) stop at 75 or younger; 1 takes children under 18; 11 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 28 studies in Dentin Sensitivity by GlaxoSmithKline as a file.
02

Study summary

The aim of this study is to develop the clinical methodology to characterize the efficacy profiles of an experimental 5% potassium nitrate (KNO3) and 0.454% stannous fluoride (SnF2) combination dentifrice and a marketed desensitizing 0.454% SnF2 only dentifrice for the relief of dentin hypersensitivity (DH), at multiple time points, over an 8 week treatment period.

Read the detailed description

This will be a single center, 8 week, randomized, controlled, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), method development study, in participants in good general health, with pre-existing self-reported tooth sensitivity, and at least two sensitive teeth (diagnosed clinically) that meet all study criteria at the screening and baseline (pre-treatment) visits.

03

Conditions studied

  • Dentin Sensitivity

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Evidence of a personally signed and dated form (ICF) indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No and relevant abnormalities in medical history or upon oral examination. b) Absence of any condition that would impact the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
  • Male participant able to father children, or female participant of and at risk for pregnancy, must agree to use a highly effective method of throughout the study and for at least 5 days after the last dose of assigned treatment. Female participant not of child-bearing potential must meet requirements as follows: Achieved status, defined as follows: cessation of regular menses for at least 12 consecutive months, with no alternative pathological or physiological cause, and have a serum follicle-stimulating hormone (FSH) level confirming post-menopausal state, Have undergone a documented hysterectomy and/or bilateral oophorectomy, Have medically confirmed ovarian failure.
  • AT Visit 1 (Screening): participant must have a) Self-reported history of DH lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: Signs of facial/cervical erosion, abrasion or gingival recession (EAR), Tooth with MGI score = 0 adjacent to the test area (exposed dentin) only and a clinical mobility of ≤1, Tooth with signs of sensitivity, as evidenced by qualifying tactile (tactile threshold ≤ 20g) and evaporative air (Schiff sensitivity score ≥ 2) sensitivity.
  • AT Visit 2 (Baseline): participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with signs of sensitivity, as evidenced by qualifying tactile (tactile threshold ≤ 20g) and evaporative air (Schiff sensitivity score ≥ 2) sensitivity at both Screening and Baseline. All teeth which meet the sensitivity criteria (tactile threshold ≤ 20g; Schiff sensitivity score ≥ 2) at Screening (Visit 1) should be assessed by tactile stimulus at Baseline (Visit 2). Those teeth which meet the required tactile threshold (Yeaple ≤20g) again at Baseline should then be assessed by evaporative air stimulus. The examiner will select two 'Test Teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at Screening and Baseline. Once these two teeth have been identified, no further testing is necessary. Test Teeth should not be adjacent to each other and preferably in different quadrants.

Exclusion criteria

Exclusion Criteria:

  • An employee of the site directly involved in the conduct of the study or a member of their immediate family; an employee of the investigational site otherwise supervised by the investigator; a GSK employee directly involved in the conduct of the study or a member of their immediate family.
  • Participation in other studies (including cosmetic studies) involving investigational drug(s) within 30 days of study entry and/or during study participation.
  • Participation in another tooth desensitizing treatment study within 8 weeks Screening.
  • Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Any condition which, in the opinion of the investigator, causes xerostomia.
  • Pregnant female participant (as evidenced by a positive urine pregnancy test).
  • Breastfeeding female participant.
  • Known or suspected intolerance or to the study materials (or closely related compounds) or any of their stated ingredients.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • Dental prophylaxis within 4 weeks of Screening.
  • Tongue or lip piercing or presence of multiple dental implants.
  • Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
  • Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
  • Teeth bleaching within 8 weeks of Screening.
  • Participant with fixed or removable partial dentures.
  • Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
  • Specific exclusions for test teeth: a) Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening, b) Tooth with exposed dentin but with deep, defective or facial restorations, c) Teeth with full crowns or veneers, d) Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentin, e) Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator.
  • Use of an oral care product indicated for the relief of dentin hypersensitivity within 8 weeks of Screening (participant will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients).
  • Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, anti-depressants, mood-altering and anti-inflammatory drugs.
  • Use of antibiotics in the 2 weeks prior to the Screening visit, or in the 2 weeks prior to the Baseline visit during the acclimatization period.
  • Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
  • Participant who requires antibiotic prophylaxis for dental procedures.
  • Participant who is unwilling or unable to comply with the Lifestyle/Study Restrictions described in the study protocol.
  • Participant who has previously been enrolled in this study.
  • Any participant who, in the judgment of the investigator, should not participate in the study.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Test dentifrice

    Participants in this arm will receive experimental dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 parts per million \[ppm\] fluoride).

    Drug: Dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride).

  • Active comparator
    Control dentifrice

    Participants in this arm will receive comparator dentifrice containing 0.454% SnF2 (1100ppm fluoride).

    Drug: Dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride).

Interventions

  • DrugDentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride).

    Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.

  • DrugDentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride).

    Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.

06

What researchers measure

Primary outcomes

  1. Mean Schiff Sensitivity Score at Baseline (Day 0)

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Lesser the Schiff sensitivity score, lesser is the sensitivity of the tooth. Mean score will be calculated as the average score of the selected two test teeth at baseline.

    Time frame: Baseline (Day 0)

  2. Mean Schiff Sensitivity Score at Day 3

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Lesser the Schiff sensitivity score, lesser is the sensitivity of the tooth. Mean score will be calculated as the average score of the two test teeth on Day 3.

    Time frame: Day 3

  3. Mean Schiff Sensitivity Score at Day 7

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Lesser the Schiff sensitivity score, lesser is the sensitivity of the tooth. Mean score will be calculated as the average score of the two test teeth on Day 7.

    Time frame: Day 7

  4. Mean Schiff Sensitivity Score at Day 14

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Lesser the Schiff sensitivity score, lesser is the sensitivity of the tooth. Mean score will be calculated as the average score of the two test teeth on Day 14.

    Time frame: Day 14

  5. Mean Schiff Sensitivity Score at Day 28

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Lesser the Schiff sensitivity score, lesser is the sensitivity of the tooth. Mean score will be calculated as the average score of the two test teeth on Day 28.

    Time frame: Day 28

  6. Mean Schiff Sensitivity Score at Day 56

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Lesser the Schiff sensitivity score, lesser is the sensitivity of the tooth. Mean score will be calculated as the average score of the two test teeth on Day 56.

    Time frame: Day 56

  7. Mean Tactile Threshold at Baseline (Day 0)

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g. Mean score will be calculated as the average score of the two test teeth on Baseline (Day 0).

    Time frame: Baseline (Day 0)

  8. Mean Tactile Threshold at Day 3

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g. Mean score will be calculated as the average score of the two test teeth on Day 3.

    Time frame: Day 3

  9. Mean Tactile Threshold at Day 7

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g. Mean score will be calculated as the average score of the two test teeth on Day 7.

    Time frame: Day 7

  10. Mean Tactile Threshold at Day 14

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g. Mean score will be calculated as the average score of the two test teeth on Day 14.

    Time frame: Day 14

  11. Mean Tactile Threshold at Day 28

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g. Mean score will be calculated as the average score of the two test teeth on Day 28.

    Time frame: Day 28

  12. Mean Tactile Threshold at Day 56

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g. Mean score will be calculated as the average score of the two test teeth on Day 56.

    Time frame: Day 56

  13. Change From Baseline (Day 0) in Schiff Sensitivity Score on Day 3

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score will indicate the improvement in sensitivity.

    Time frame: Baseline (Day 0), Day 3

  14. Change From Baseline (Day 0) in Schiff Sensitivity Score on Day 7

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score will indicate the improvement in sensitivity.

    Time frame: Baseline (Day 0), Day 7

  15. Change From Baseline (Day 0) in Schiff Sensitivity Score on Day 14

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score will indicate the improvement in sensitivity.

    Time frame: Baseline (Day 0), Day 14

  16. Change From Baseline (Day 0) in Schiff Sensitivity Score on Day 28

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score will indicate the improvement in sensitivity.

    Time frame: Baseline (Day 0), Day 28

  17. Change From Baseline (Day 0) in Schiff Sensitivity Score on Day 56

    The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score will indicate the improvement in sensitivity.

    Time frame: Baseline (Day 0), Day 56

  18. Change From Baseline (Day 0) in Tactile Threshold on Day 3

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g.

    Time frame: Baseline (Day 0), Day 3

  19. Change From Baseline (Day 0) in Tactile Threshold on Day 7

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g.

    Time frame: Baseline (Day 0), Day 7

  20. Change From Baseline (Day 0) in Tactile Threshold on Day 14

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g.

    Time frame: Baseline (Day 0), Day 14

  21. Change From Baseline (Day 0) in Tactile Threshold on Day 28

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g.

    Time frame: Baseline (Day 0), Day 28

  22. Change From Baseline (Day 0) in Tactile Threshold on Day 56

    The examiner will assess the response to tactile sensitivity using a Yeaple probe which will allow application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force will reach. The tactile threshold for each tooth will be determined by asking the participants whether the sensation caused discomfort. The pressure setting at which the participant will give two consecutive 'yes' responses will be recorded as the tactile threshold. Higher tactile threshold will indicate the less sensitive are the tooth. At baseline, the maximum force will be 20g; at all subsequent visits, it will be 80g. However, in situations where participants will not give a 'yes' response at force of 80g, the tactile threshold will be recorded as \>80g.

    Time frame: Baseline (Day 0), Day 56

  23. Number of sensitive teeth (Schiff sensitivity score ≥ 1) on Day 0 (Baseline)

    The number of teeth with a Schiff sensitivity score of ≥1 will be consider sensitive teeth. Schiff sensitivity scores were as follows:0= Subject does not respond to air stimulation, 1= if participants respond to air stimulus but does not request discontinuation of stimulus; 2= participants respond to air stimulus and requests discontinuation or moves from stimulus; 3 = participants respond to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    Time frame: Baseline (Day 0)

  24. Number of sensitive teeth (Schiff sensitivity score ≥ 1) on Day 3

    The number of teeth with a Schiff sensitivity score of ≥1 will be consider sensitive teeth. Schiff sensitivity scores were as follows:0= Subject does not respond to air stimulation, 1= if participants respond to air stimulus but does not request discontinuation of stimulus; 2= participants respond to air stimulus and requests discontinuation or moves from stimulus; 3 = participants respond to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    Time frame: Day 3

  25. Number of sensitive teeth (Schiff sensitivity score ≥ 1) on Day 7

    The number of teeth with a Schiff sensitivity score of ≥1 will be consider sensitive teeth. Schiff sensitivity scores were as follows:0= Subject does not respond to air stimulation, 1= if participants respond to air stimulus but does not request discontinuation of stimulus; 2= participants respond to air stimulus and requests discontinuation or moves from stimulus; 3 = participants respond to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    Time frame: Day 7

  26. Number of sensitive teeth (Schiff sensitivity score ≥ 1) on Day 14

    The number of teeth with a Schiff sensitivity score of ≥1 will be consider sensitive teeth. Schiff sensitivity scores were as follows:0= Subject does not respond to air stimulation, 1= if participants respond to air stimulus but does not request discontinuation of stimulus; 2= participants respond to air stimulus and requests discontinuation or moves from stimulus; 3 = participants respond to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    Time frame: Day 14

  27. Number of sensitive teeth (Schiff sensitivity score ≥ 1) on Day 28

    The number of teeth with a Schiff sensitivity score of ≥1 will be consider sensitive teeth. Schiff sensitivity scores were as follows:0= Subject does not respond to air stimulation, 1= if participants respond to air stimulus but does not request discontinuation of stimulus; 2= participants respond to air stimulus and requests discontinuation or moves from stimulus; 3 = participants respond to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    Time frame: Day 28

  28. Number of sensitive teeth (Schiff sensitivity score ≥ 1) on Day 56

    The number of teeth with a Schiff sensitivity score of ≥1 will be consider sensitive teeth. Schiff sensitivity scores were as follows:0= Subject does not respond to air stimulation, 1= if participants respond to air stimulus but does not request discontinuation of stimulus; 2= participants respond to air stimulus and requests discontinuation or moves from stimulus; 3 = participants respond to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

    Time frame: Day 56

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2018; primary completion for Dec 2018, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2017
First posted
Dec 5, 2017
StartEst.
Oct 1, 2018
Primary completionEst.
Dec 3, 2018
CompletionEst.
Dec 3, 2018
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03361774
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 5, 2017
Start date
Oct 1, 2018 (estimated)
Primary completion
Dec 3, 2018 (estimated)
Completion
Dec 3, 2018 (estimated)
Last update
Feb 15, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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