Clinical Study to Investigate the Ability of a Stannous Fluoride Toothpaste to Protect From Dentine Hypersensitivity

NCT06733285 | Completed

• 1 other identifier: 300212
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate and characterize the Dentine Hypersensitivity (DH) protection profiles of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste and a regular fluoride toothpaste, in response to evaporative air (Schiff sensitivity score) and tactile (tactile threshold in grams \[g\]) stimuli, with twice daily brushing over 2 weeks.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (6)

• Least Square (LS) Mean Change from Baseline in Schiff Sensitivity Score at Day 15

  Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges 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 and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. LS means of change from baseline at Day 15 will be estimated using a Mixed Model with Repeated Measures (MMRM). A decrease in Schiff sensitivity score indicates an improvement.

  Baseline (Day 1) and Day 15

• LS Mean Change from Baseline in Tactile Threshold at Day 15

  The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. LS means of change from baseline at Day 15 will be estimated using a MMRM.

  Baseline (Day 1) and Day 15

• Schiff Sensitivity Score at Baseline, Day 2, Day 8, and Day 15

  Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges 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 and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. A decrease in Schiff sensitivity score indicates an improvement.

  Baseline (Day 1), Days 2, 8 and 15

• Tactile Threshold at Baseline, Day 2, Day 8, and Day 15

  The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 2, 8 and 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline.

  Baseline (Day 1), Days 2, 8 and 15

• Change From Baseline in Schiff Sensitivity Score at Day 2, Day 8, and Day 15

  Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges 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 and requests discontinuation of the stimulus. Schiff sensitivity score= average score of the 2 'test teeth' identified at baseline. Change from baseline will be calculated by subtracting baseline score from the score at the indicated timepoints. A decrease in Schiff sensitivity score indicates an improvement.

  Baseline (Day 1), Days 2, 8 and 15

• Change From Baseline in Tactile Threshold at Day 2, Day 8, and Day 15

  The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. At baseline the upper test limit is 20 g and at Day 15, the upper test limit is 80 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Tactile threshold= average value for the two 'test teeth' identified at baseline. Change from baseline will be calculated by subtracting LS mean baseline score from the score at the indicated timepoints.

  Baseline (Day 1), Days 2, 8 and 15

Secondary Outcomes (4)

• LS Mean Change from Baseline in Schiff Sensitivity Score at Day 2 and Day 8

  Baseline (Day 1), Days 2 and 8

• LS Mean Change from Baseline in Tactile Threshold (g) at Day 2 and Day 8

  Baseline (Day 1), Days 2 and 8

• LS Mean Change from Baseline in Schiff Sensitivity Score at Day 2, Day 8 and Day 15 (Test Versus [Vs] Negative Control)

  Baseline (Day 1), Days 2, 8 and 15

• LS Mean Change from Baseline in Tactile Threshold (g) at Day 2, Day 8 and Day 15 (Test Vs Negative Control)

  Baseline (Day 1), Days 2, 8 and 15

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Participants will dose the toothbrush with a ribbon of test toothpaste, across the full brush head and brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for 2 weeks, making sure to brush the sensitive areas of the two 'test teeth' carefully first.

Drug: Sensodyne Rapid Relief

Regular Fluoride Toothpaste (Negative Control)

ACTIVE COMPARATOR

Participants will dose the toothbrush with a ribbon of regular fluoride toothpaste, across the full brush head and brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for 2 weeks.

Drug: Colgate Cavity Protection

Interventions

Sensodyne Rapid Relief DRUG

Toothpaste containing 0.454 % weight/weight (w/w) SnF2 (1100 parts per million \[ppm\] fluoride).

Test Toothpaste

Colgate Cavity Protection DRUG

A regular fluoride toothpaste containing 1000 ppm fluoride.

Regular Fluoride Toothpaste (Negative Control)

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
• Participant is biologically male or female.
• Participant is 18 to 70 years of age, inclusive, at the time of signing the consent form.
• Participant is willing and able to comply with the study visit schedule, toothpaste 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, with 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)
• Participants 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 non-adjacent, accessible teeth (incisors, canines, premolars), in different quadrants, which meet all the following criteria:
• Exposed dentine due to facial/cervical erosion or abrasion (that is, tooth wear) or gingival recession (EAR).
• Modified Gingival Index (MGI)= 0 directly adjacent to the exposed dentine (that is, the test area only).
• Clinical mobility= 0.
• Clinically confirmed DH to both tactile and evaporative (air) stimuli: Tactile threshold less than or equal to (\<=) 20g and Schiff sensitivity score more than or equal to (\>=) 2.
• 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 such a product within 8 weeks of Screening (Visit 1).
• 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): 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-sensitizing treatment within 8 weeks of Screening (Visit 1).

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

University of Bristol, Bristol Dental School and Hospital

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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: December 10, 2024
• First Posted: December 13, 2024
• Study Start: February 4, 2025
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 3, 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

GB (1)