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
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.
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.
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 →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.
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Exclusion Criteria:
Participant who:
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.
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.
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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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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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
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
A marketed toothpaste containing 0.454 percent (%) SnF2.
A marketed toothpaste containing 0.3152% Weight on Weight (w/w) Sodium Fluoride (NaF).
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
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
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
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
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.
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 ↗
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