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

NCT07842042 | Not Yet Recruiting

• 1 other identifier: 400370
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

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.

  Baseline (Day 0) and Day 3, 7, 10 and 14

Secondary Outcomes (3)

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

  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

  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

  Baseline (Day 0) and Day 3, 7, 10 and 14

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

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

Reference Toothpaste

OTHER

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

Test Toothpaste OTHER

A marketed toothpaste containing 0.454 percent (%) SnF2.

Test Toothpaste

Regular Fluoride Toothpaste OTHER

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

Reference Toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provision of a signed and dated informed consent 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 clinically significant 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).

You may not qualify if:

• A participant who is an employee of the investigational 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 hypersensitivity 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:
• Is taking antibiotics during the study or has taken antibiotics in the two weeks prior to the screening visit.
• 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.
• Currently taking a systemic medication (e.g., anti-inflammatory, anticoagulant, immunosuppressants) 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).
• Smokes or uses smokeless forms of tobacco (example \[e.g.\] chewing tobacco, gutkha, pan containing tobacco, e-cigarettes \[vapes\]).
• Is diagnosed with xerostomia or who the investigator believes might suffer from xerostomia based upon medications or oral examination.
• 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.
• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

University of Birmingham

Birmingham, B5 7EG, United Kingdom

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Praveen Sharma

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haleon Response Center

CONTACT

+441932 95 95 00; ww.clinical-trial-register@haleon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

GB (1)