A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population

NCT04950465 | Completed Results

• 1 other identifier: 216954
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)

  Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.

  Baseline and Week 8

Secondary Outcomes (4)

• Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)

  Baseline, Week 4 and 8

• Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)

  Baseline and Week 4

• Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)

  Baseline, Week 4 and Week 8

• Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)

  Baseline, Week 4 and Week 8

Study Arms (3)

Test Dentifrice

EXPERIMENTAL

Apply a full ribbon of toothpaste on the head of the toothbrush provided. Brush teeth for 1\*-timed minute, followed by brushing of the qualifying sensitive teeth. Following brushing rinse once with 10 milliliter (ml) of water from the rinsing cup provided.

Other: Sensodyne Sensitivity & Gum

Negative Control

ACTIVE COMPARATOR

Apply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1\* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided.

Other: Crest Cavity Protection Fresh Lime

Positive Control

ACTIVE COMPARATOR

Apply a full ribbon of toothpaste on the head of the toothbrush provided; brush teeth for 1\* timed minute. Following brushing rinse once with 10 ml of water from the rinsing cup provided.

Other: Sensodyne Repair and Protect

Interventions

Sensodyne Sensitivity & Gum OTHER

Sensodyne Sensitivity \& Gum toothpaste containing 0.454% SnF2.

Test Dentifrice

Crest Cavity Protection Fresh Lime OTHER

Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride.

Negative Control

Sensodyne Repair and Protect OTHER

Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate.

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 assessment is performed.
• A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
• A participant 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.
• Self-reported history of dentinal hypersensitivity lasting more than six months but not more than 10 years.
• 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, that meet all of the following criteria:
• i. Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
• ii. Tooth with MGI score ≤1 adjacent to the test area (exposed dentine) only and a clinical mobility of less than or equal to (\<=)1.
• iii. Tooth with signs of sensitivity measured by a qualifying tactile stimulus (yeaple \[\<=\] 20 gram \[g\]) and qualifying evaporative air assessment (Schiff sensitivity score more than or equal to (\>=) 2).
• d) Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), with signs of sensitivity, measured by response to a qualifying tactile stimulus (yeaple \<= 20g) and evaporative air assessment (Schiff sensitivity score \>=2). The 2 selected 'test teeth' must have also qualified at Screening for this criteria.
• \- Participant must own a smartphone with the WeChat application installed.

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 GSK CH 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 who has participated in another tooth desensitising treatment study within 8 weeks of the Screening visit.
• A participant with, in the opinion of the investigator or medically qualified designee, has 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 pregnant or intending to become pregnant over the duration of the study. This will be confirmed verbally at Screening.
• A participant who is breastfeeding.
• 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 who rinses with water during the first minute of toothbrushing at the Screening visit.
• A participant unwilling or unable to comply with product usage instructions or Lifestyle Considerations that will be described in the protocol.
• A participant with history of regular alcohol and/or substance abuse.
• A participant who has received treatment with another investigational product within 30 days of the first dose of investigational product.
• A participant who has had dental prophylaxis within 4 weeks of Screening, or who requires antibiotic prophylaxis for dental procedures.
• A participant with a tongue or lip piercing.
• A participant with advanced periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
• A participant who has had teeth bleaching within 8 weeks of Screening.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

GSK Investigational Site

Shanghai, 200011, China

Location

Related Publications (1)

• Li R, Yang W, Grimaldi R, Zeng P, Smith G, Chen X. Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial. Clin Oral Investig. 2024 Mar 26;28(4):230. doi: 10.1007/s00784-024-05610-9.

  PMID: 38530474 DERIVED

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

+44 7880 182593

Study Officials

• GSK Clinical Trials

  Preventive Dentistry Depart-ment, Shanghai Ninth Peo-ple's Hospital, Shanghai Jiao-tong University, School of Medicine

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 6, 2021
• Study Start: July 27, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a 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)