ClinicalTrials.gg
RecruitingNCT07842042Updated Oct 9, 2026

A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride

An interventional study of Test Toothpaste and Regular Fluoride Toothpaste in Dental Plaque and Gingivitis, sponsored by HALEON. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by HALEON · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 9, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The aim of this study is to evaluate the feasibility, sensitivity, and interpretability of gingival crevicular fluid (GCF) cytokine biomarkers as early indicators of tissue recovery following use of commercial dentifrice compared with a standard fluoride dentifrice in experimental gingivitis model, after 14 days twice daily use.

Read the detailed description

This will be a single-center, randomized, controlled, double-blind, split-mouth, 2 treatment arms, parallel group, stratified clinical study in healthy participants with gingivitis and plaque accumulation induced using an experimental gingivitis model, to characterize GCF biomarkers associated with gingival health over time following use of a Test Toothpaste containing stannous fluoride (SnF2) compared to a Regular Fluoride Toothpaste (Reference Toothpaste) on GCF biomarkers. Sufficient participants will be screened to randomize approximately 20 participants (10 per group) to ensure approximately 18 (9 per group) evaluable participants complete the entire study.

02

Conditions studied

  • Dental Plaque
  • Gingivitis
03

In context

Dental Plaque

352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.

This study's planned enrollment of 20 is below the median of 56 across 316 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 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

  • Participant provision of a signed and dated document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • A participant is willing and able to comply with scheduled visits, and other study procedures and restrictions including the lifestyle restrictions.
  • A participant is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • A participant with probing pocket depths of less than (\<) 3.5mm and a minimum of four teeth from maxillary canine to third molar in both maxillary quadrants that are scorable (including two molars and at least one premolar) at screening.
  • A participant has, localized, plaque induced gingivitis at screening, defined as >= 10 and less than equal to (\<=) 30% of sites exhibiting bleeding on probing (BOP).
  • A participants have a canine, one or two premolars, and two or three molars present in each maxillary quadrant (right and left side).

Exclusion criteria

Exclusion Criteria:

  • A participant who is an employee of the site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
  • A participant with, in the opinion of the investigator or medically qualified designee, an 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 or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A participant who is breast feeding, is pregnant (self-reported) or intending to become pregnant over the duration of the study.
  • A participant with known or suspected intolerance or to the study materials (or closely related compounds) or any of their stated ingredients.
  • A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.
  • A participant with a recent history (within the last year) of alcohol or other substance abuse.
  • Participant who:

    1. Is taking antibiotics during the study or has taken antibiotics in the two weeks prior to the screening visit.
    2. Is using or has used an anti-bacterial toothpaste/mouthwash (e.g., chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health.
    3. Currently taking a systemic medication (e.g., anti-inflammatory, anticoagulant, ) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g., ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
    4. Smokes or uses smokeless forms of tobacco (example [e.g.] chewing tobacco, gutkha, pan containing tobacco, e-cigarettes [vapes]).
    5. Is diagnosed with xerostomia or who the investigator believes might suffer from xerostomia based upon medications or oral examination.
    6. Has a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush.
    7. Has, in the opinion of the investigator or medically qualified designee, signs of active periodontal disease or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
    8. Requires immediate dental intervention to resolve any oral condition.
    9. Has dentures (partial or full) or has an orthodontic appliance (bands, appliances, or fixed/ removable retainers) that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush.
    10. A participant who has had teeth bleaching within 12 weeks of Screening.
  • A participant who has previously been enrolled in this study.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Terms in these criteria, in plain language(5)

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.

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Test Toothpaste

    Participants will brush their teeth with a full ribbon of Test Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening) for 14 days.

    Other: Test Toothpaste

  • Other
    Reference Toothpaste

    Participants will brush their teeth with full ribbon of Reference Toothpaste on the head of the toothbrush thoroughly for at least one (timed) minute twice a day (morning and evening) for 14 days.

    Other: Regular Fluoride Toothpaste

Interventions

  • OtherTest Toothpaste

    A marketed toothpaste containing 0.454 percent (%) SnF2.

  • OtherRegular Fluoride Toothpaste

    A marketed toothpaste containing 0.3152% Weight on Weight (w/w) Sodium Fluoride (NaF).

06

What researchers measure

Primary outcomes

  1. GCF Biomarkers Profile Assessment at Baseline (Day 0), Day 3, 7, 10 and 14

    GCF samples will be collected from the mesio-buccal site of the selected teeth. Proteins will be eluted from the pooled collection papers and then analysed by proximity extension assay.

    Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14

Secondary outcomes

  1. GCF Volume at Baseline (Day 0), Day 3, 7, 10 and 14

    GCF samples will be collected from the mesio-buccal site of the selected teeth. The volume of GCF collected on each strip will be quantified using a Periotron device, which measures the fluid absorbed by the PerioPaper strips and provides an estimate of GCF volume.

    Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14

  2. Change from Baseline in Modified Gingival Index (MGI) at Day 3, 7, 10 and 14

    The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed for all evaluable teeth, four sites per test and reference tooth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2= Mild inflammation: criteria as (1) but involving the entire marginal or papillary gingival unit, 3= Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4= Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. Lower score will indicate an improvement in condition.

    Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14

  3. Change from Baseline in Turesky modification of the Quigley Hein Plaque Index (TPI) at Day 3, 7, 10 and 14

    TPI will be used to assess plaque on all gradable test and reference teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Separate flecks of plaque at the cervical margin, 2= Thin continuous band of plaque \[up to 1 millimeter (mm)\] at the cervical margin, 3= Band of plaque wider than 1 mm but covering less than (\<) 1/3 of the tooth surface, 4= Plaque covering more than equal to (\>=) 1/3 but \< 2/3 of the tooth surface, 5= Plaque covering \>= 2/3 of the tooth surface. Change from baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. Lower score will indicate improvement in gingival health.

    Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 9, 2026
Sites
University of Birmingham is now Recruiting
Oct 9, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 2 updates
  1. Oct 9, 2026
    Not yet recruiting→Recruiting
    University of Birmingham is now Recruiting
    + 2 other changes: verification date and date precision
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07842042
Lead sponsor
HALEON
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Sep 28, 2026
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Oct 9, 2026

Study contacts

Haleon Response Center
Contact
ww.clinical-trial-register@haleon.com
+441932 95 95 00
Praveen Sharma
principal investigator · University of Birmingham

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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