CompletedNCT02731833Updated May 17, 2017Results posted

Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

A Phase 4 interventional study of stannous fluoride and sodium monofluorophosphate in Dentin Sensitivity, sponsored by GlaxoSmithKline. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 229
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice

Read the detailed description

This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. Dentinal hypersensitivity will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing

Conditions studied

Dentin Sensitivity

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Dentin Sensitivity 289

In context

Dentin Sensitivity

289 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.

This study's enrollment of 229 is above the median of 60 across 280 interventional studies indexed under Dentin Sensitivity.

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Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

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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

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
Aged 18-65 years inclusive
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination. b) Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years
Minimum of 20 natural teeth
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 gingival recession and/or signs of erosion or abrasion (EAR), Tooth with MGI score =0 adjacent to the test area (exposed dentine) only [Lobene, 1986] and a clinical mobility of ≤1, Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria: Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2)

Exclusion criteria

Exclusion Criteria:

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Women who are breast-feeding
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
Previous participation in this study
Recent history (within the last year) of alcohol or other substance abuse
An employee of the sponsor or the study site or members of their immediate family
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or Any condition which, in the opinion of the investigator, causes xerostomia
Dental prophylaxis within 4 weeks of Screening or Tongue or lip piercing or presence of 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 and teeth bleaching within 8 weeks of Screening
Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening
Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine
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 dentine hypersensitivity within 8 weeks of screening (participants 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, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs
Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 229 participants (actual)

Study arms

Experimental
Test dentifrice
Participants will be instructed to dose a dry toothbrush with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute
Other: stannous fluoride
Active comparator
Control dentifrice
Participants will be instructed to dose a dry toothbrush with a full strip (1 inch) of toothpaste. Participants will then brush whole mouth thoroughly for at least 1 minute
Other: sodium monofluorophosphate

Interventions

Otherstannous fluoride
0.454% weight by weight (w/w) stannous fluoride containing 1100ppm fluoride
Othersodium monofluorophosphate
0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride

What researchers measure

Primary outcomes

Change From Baseline in Schiff Sensitivity Score on Day 3
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
Time frame: Baseline to Day 3

Secondary outcomes

Change From Baseline in Tactile Threshold on Day 3
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed 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 was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.
Time frame: Baseline to Day 3
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
Time frame: Baseline to 60 seconds post first treatment
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed 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 was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.
Time frame: Baseline to 60 seconds post first treatment

Results

Posted Mar 15, 2017

Participant flow

Participants were recruited at single clinical site in Canada.

Participant flow — Overall Study
Milestone	Stannous Fluoride	Sodium Monofluorophosphate
Started	111	111
Completed	111	111
Not completed	0	0

Outcome measures

PrimaryChange From Baseline in Schiff Sensitivity Score on Day 3

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

Time frame:: Baseline to Day 3
Reported as:: Mean · Score on a scale

Change From Baseline in Schiff Sensitivity Score on Day 3
Score on a scale	Stannous Fluoride	Sodium Monofluorophosphate
Change From Baseline in Schiff Sensitivity Score on Day 3	-0.40 ± 0.485	0.00 ± 0.257

Statistical analysis

Stannous Fluoride vs Sodium Monofluorophosphate · ANCOVA · p = <0.0001 · Least square (ls) mean difference: -0.40 · 95% CI -0.505 to -0.300Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.

SecondaryChange From Baseline in Tactile Threshold on Day 3

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed 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 was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.

Time frame:: Baseline to Day 3
Reported as:: Mean · g

Change From Baseline in Tactile Threshold on Day 3
g	Stannous Fluoride	Sodium Monofluorophosphate
Change From Baseline in Tactile Threshold on Day 3	3.69 ± 4.941	0.09 ± 2.521

SecondaryChange From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application

Time frame:: Baseline to 60 seconds post first treatment
Reported as:: Mean · Score on a scale

Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
Score on a scale	Stannous Fluoride	Sodium Monofluorophosphate
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application	-0.17 ± 0.340	-0.02 ± 0.269

SecondaryChange From Baseline in Tactile Threshold Post First Treatment by Direct Application

Time frame:: Baseline to 60 seconds post first treatment
Reported as:: Mean · g

Change From Baseline in Tactile Threshold Post First Treatment by Direct Application
g	Stannous Fluoride	Sodium Monofluorophosphate
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application	1.71 ± 3.268	0.18 ± 2.328

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Stannous Fluoride	—	0/111 (0%)	0/111 (0%)
Sodium Monofluorophosphate	—	0/111 (0%)	0/111 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Stannous Fluoride	Sodium Monofluorophosphate	Total
Mean	46.4 ± 10.77	47.6 ± 10.95	47.0 ± 10.85

Sex: Female, Male
Sex: Female, Male(Participants)	Stannous Fluoride	Sodium Monofluorophosphate	Total
Female	82	81	163
Male	29	30	59

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Stannous Fluoride	Sodium Monofluorophosphate	Total
Hispanic or Latino	2	1	3
Not Hispanic or Latino	109	110	219
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Stannous Fluoride	Sodium Monofluorophosphate	Total
American Indian or Alaska Native	0	0	0
Asian	18	15	33
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	33	23	56
White	60	73	133
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Schiff Sensitivity Score at Baseline
Schiff Sensitivity Score at Baseline(Score on a Scale)	Stannous Fluoride	Sodium Monofluorophosphate	Total
Mean	2.50 ± 0.484	2.46 ± 0.461	2.48 ± 0.472

Tactile Sensitivity - Tactile Threshold at Baseline
Tactile Sensitivity - Tactile Threshold at Baseline(gram (g))	Stannous Fluoride	Sodium Monofluorophosphate	Total
Mean	12.66 ± 4.201	13.42 ± 4.263	13.04 ± 4.240

Study locations

1 site

GSK Investigational Site
Mississauga, Ontario L4W 0C2, Canada

References and documents

Publications

Creeth J, Gallob J, Sufi F, Qaqish J, Gomez-Pereira P, Budhawant C, Goyal C. Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief. BMC Oral Health. 2019 Jun 4;19(1):98. doi: 10.1186/s12903-019-0781-x. PubMed 31164116 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02731833
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Apr 8, 2016
Start date: Apr 1, 2016
Primary completion: May 1, 2016
Completion: May 20, 2016
Results posted: Mar 15, 2017
Last update: May 17, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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