A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

NCT05750745 | Completed Results

• 1 other identifier: 300026
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice Versus [vs.] Negative Control)

  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 was scored using Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3 where 0=Participant did not respond to air stimulation; 1=Participant responded to air stimulus but did not request discontinuation of stimulus; 2=Participant responded to air stimulus and requested discontinuation or moved from stimulus; 3=Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. Higher score indicated worse outcome (more sensitivity). Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoint. Baseline was defined as Day 1 value. A negative change from Baseline indicated improvement in sensitivity.

  Baseline and Week 12

Secondary Outcomes (8)

• Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)

  Baseline and Week 12

• Adjusted Mean Change From Baseline in Visual Analog Scale (VAS) Score (Millimeters [mm]) (Average of the Two Selected Test Teeth) at Week 12 (Test Dentifrice vs. Negative Control)

  Baseline and Week 12

• Adjusted Mean Change From Baseline in Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

  Baseline and Week 6

• Adjusted Mean Change From Baseline in Tactile Threshold (g) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

  Baseline and Week 6

• Adjusted Mean Change From Baseline in VAS Score (mm) (Average of the Two Selected Test Teeth) at Week 6 (Test Dentifrice vs. Negative Control)

  Baseline and Week 6

Study Arms (3)

Test Dentifrice

EXPERIMENTAL

Participants will be instructed to brush the two test teeth first, then the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Sensodyne Sensitivity \& Gum. After brushing, participants will be instructed to rinse once with 10 milliliters (mL) of water using the measuring cup provided.

Drug: Sensodyne Sensitivity & Gum

Negative Control

ACTIVE COMPARATOR

Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Crest Cavity Protection Fresh Lime. After brushing, participants will be instructed to rinse once with 10 mL of water using the measuring cup provided.

Drug: Crest Cavity Protection Fresh Lime

Positive Control

ACTIVE COMPARATOR

Participants will be instructed to brush the whole mouth (all teeth) for 1-timed minute, twice daily (morning and evening) with Sensodyne Repair and Protect. After brushing, participants will be instructed to rinse once with 10 mL of water using the measuring cup provided.

Drug: Sensodyne Repair and Protect

Interventions

Sensodyne Sensitivity & Gum DRUG

Sensodyne Sensitivity \& Gum toothpaste is containing 0.454% w/w SnF2.

Test Dentifrice

Crest Cavity Protection Fresh Lime DRUG

Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).

Negative Control

Sensodyne Repair and Protect DRUG

Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).

Positive 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:

• 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 study procedures are performed.
• Participant who is willing and able to understand and comply with scheduled visits, product usage requirements and other study procedures.
• A participant 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 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.
• Participant who owns a smartphone with the WeChat application installed.
• Self-reported history of tooth sensitivity lasting more than six months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently (as mentioned in Screening questionnaire).
• Good general oral health, with a minimum of 20 natural teeth.
• Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH.
• Each eligible tooth must meet all of the following criteria:
• Exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
• Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentine (i.e., the test area) only
• Clinical mobility = 0.
• DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to \[\<=\] 20 g and Schiff sensitivity score more than or equal to \[\>=\] 2).
• All teeth identified at Screening (Visit 1) as eligible for Baseline assessments will be reassessed for tactile sensitivity first; eligible teeth with Baseline tactile threshold \<= 20g will then be re-assessed for evaporative (air) sensitivity.
• Participants must have a minimum of two non-adjacent, accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically confirmed DH as evidenced by qualifying levels of tactile and evaporative (air) sensitivity:
• Tactile threshold \<= 20 g at Screening and Baseline

You may not qualify if:

• Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
• Participant who has participated in, or has participated in, other studies (including non-medicinal studies) involving investigational product(s) within 30 days of Screening (Visit 1).
• Participant who is participating in, has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
• Participant who is using, or has used, an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1). Participant will be required to bring their current oral care products to Visit 1 for staff to verify the absence of known anti-sensitivity ingredients and DH claims.
• Participant who has had a professional de-sensitizing treatment within 8 weeks of Screening (Visit 1).
• Participant who habitually rinses with water during toothbrushing (self-reported at Screening Visit 1).
• Participant who seen to rinse with water while brushing with the acclimatization toothpaste during review of their brushing compliance videos at Baseline (Visit 2).
• Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
• Participant who is unwilling or unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol.
• Female participant who is pregnant or intending to become pregnant during the study (self-reported).
• Female participant who is breastfeeding.
• Participant with a recent history (within the last year) of alcohol and/or substance abuse.
• 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 study 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.
• Participant taking daily doses of medications or traditional herbal treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of pain.
• Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood altering and anti-inflammatory drugs.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Department of Preventive Dentistry, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200011, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: May 8, 2023
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

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

CN (1)