Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers

NCT06359028 | Completed Results

• 1 other identifier: 300103
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56

  Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicated an improvement.

  Baseline and Day 56

Secondary Outcomes (12)

• Adjusted Mean Change From Baseline in Tactile Threshold at Day 56

  Baseline and Day 56

• Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28

  Baseline and Day 28

• Adjusted Mean Change From Baseline in Tactile Threshold at Day 28

  Baseline and Day 28

• Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56

  Baseline, Day 28 and Day 56

• Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56

  Baseline, Day 28 and Day 56

Study Arms (2)

Test toothpaste

EXPERIMENTAL

Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wish to rinse after brushing will be instructed to rinse with 10 milliliter (ml) water using graduated rinsing cup provided.

Drug: Stannous fluoride toothpaste

Reference toothpaste (Negative control)

ACTIVE COMPARATOR

Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wish to rinse after brushing will be instructed to rinse with 10 ml water using graduated rinsing cup provided.

Drug: Crest cavity protection toothpaste

Interventions

Stannous fluoride toothpaste DRUG

Toothpaste containing 0.454 % weight/weight (w/w) SnF2

Test toothpaste

Crest cavity protection toothpaste DRUG

Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride.

Reference toothpaste (Negative control)

Eligibility Criteria

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

You may qualify if:

• Participant provision of signed and dated informed consent before any study procedures are performed.
• Participant is male or female.
• Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent.
• Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
• Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
• Screening (Visit 1): Participant must have-
• History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
• Good general oral health, with a minimum of 20 natural teeth.
• Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:
• Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
• Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).
• Clinical mobility = 0
• Clinically confirmed DH to both tactile and evaporative (air) stimuli: a) Qualifying tactile threshold less than or equal to (\<=) 20g. b) Qualifying Schiff sensitivity score more than or equal to (\>=) 2.
• Baseline (Visit 2, Pre-Treatment)
• Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both screening (Visit 1) and baseline (Visit 2).

You may not qualify if:

• Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
• Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
• Female participant who is pregnant or intending to become pregnant during the study (self-reported).
• Female participant who is breastfeeding (self-reported).
• Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
• Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
• Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
• Participant has participated in a tooth sensitivity study within 8 weeks of screening (Visit 1).
• Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of screening (Visit 1). Participants will be required to bring their current oral care products to screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text.
• Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
• Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to screening (Visit 1).
• Baseline (Visit 2, Pre-Treatment): Participant has taken antibiotics in the 2 weeks prior to baseline (Visit 2), that is, during the acclimatization period.
• Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
• Participant requires antibiotic prophylaxis for dental procedures.
• Participant has had professional tooth de-sensitising treatment within 8 weeks of screening (Visit 1).

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Salus Research

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 11, 2024
• Study Start: March 25, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

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

US (1)