A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management

NCT06045026 | Completed Results

• 1 other identifier: 300058
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) on oral health related quality of life (OHrQoL) in a population of self-reported dentin hypersensitivity (DH) sufferers. Data generated will provide real world information on the DH experience and DH management with a daily use anti-sensitivity treatment.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (6)

• Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24

  The DHEQ is a condition-specific measure of oral-health related quality-of-life (OHrQoL) in relation to dentin hypersensitivity (DH). Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better quality of life in relation to DH. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL.

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24

  Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24

  Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24

  Social Impact domain of DHEQ evaluates 'the way the sensations affect participants when they are with other people or in certain situations.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life).

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24

  Emotional Impact Domain of DHEQ evaluated 'the way the sensations in participant's teeth make them feel.' It included 8 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL (less impact of sensations on participant's emotions).

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24

  Identity Domain of DHEQ evaluated 'what the sensations in participant's teeth mean for them.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity).

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

Secondary Outcomes (7)

• Adjusted Mean Change From Baseline in Impact on Everyday Life (DHEQ Section 1, Q1-3) Score at Weeks 4, 8, 12, 16, 20 and 24

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24

• Percentage of Participants Who 'Agree' (Score 5-7) With Each Item (Statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24

  Baseline (Week 0) and Week 24

• Adjusted Mean Change From Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24

  Baseline (Week 0) and Weeks 1, 2, 4, 8, 12, 16, 20, 24

Study Arms (1)

Anti-sensitivity toothpaste

OTHER

Participants will use the anti-sensitivity toothpaste according to the instructions on the commercial pack and their normal oral healthcare habits for 24 weeks.

Other: Stannous fluoride

Interventions

Stannous fluoride OTHER

Anti-sensitivity toothpaste containing 0.454% Stannous Fluoride

Anti-sensitivity toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
• All genders who, at the time of screening, are aged between 18 and 65 years (inclusive).
• Participant who is willing to complete all the assigned activities.
• Participant who is able to independently complete all the assigned activities on their smart devices.
• Participant who has tooth sensitivity (self-reported symptoms).

You may not qualify if:

• Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:
• Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
• Participant with full or partial denture(s).
• Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
• Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
• Participant who has been informed by a DHCP that they have active caries.
• Participant with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications (more than 3 days a week).
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

ObvioHealth Virtual Site

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tin Fluorides

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 21, 2023
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

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)