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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

Primary Purpose

Dentin Sensitivity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stannous fluoride

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

ObvioHealth Virtual SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Anti-sensitivity toothpaste

Arm Description

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

Outcomes

Primary Outcome Measures

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 OHrQoL in relation to DH which contains total 34 questions in section 2, each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 34 to 238, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Change from Baseline in DHEQ Restrictions Domain (Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24

Restrictions domain in DHEQ evaluates the ways in which any sensations in teeth affect participant's daily life. This contains 4 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 4 to 28, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Change from Baseline in DHEQ Adaptation Domain Score (Q5-16) at Weeks 4, 8, 12, 16, 20 and 24

Adaptation domain in DHEQ evaluates 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This contains 12 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 12 to 84, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Change from Baseline in DHEQ Social Impact Domain (Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24

Social Impact domain in DHEQ evaluates the way the sensations affect participants when they are with other people or in certain situations. This contains 5 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Change from Baseline in DHEQ Emotional Impact Domain (Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24

Emotional Impact Domain in DHEQ evaluates the way the sensations in participant's teeth make them feel. This contains 8 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 8 to 56, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Change from Baseline in DHEQ Identity Domain (Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24

Identity Domain in DHEQ evaluates what the sensations in participant's teeth mean for them. This contains 5 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Secondary Outcome Measures

Change from Baseline in Impact on Everyday Life (Section 1, Q1-3) at Weeks 4, 8, 12, 16, 20 and 24

DHEQ section 1 consist of 3 questions about teeth sensation and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranging from 3 to 30; where lower score indicates less sensitivity and less impact on everyday life. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Change from Baseline in Global Oral Health (Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24

Global Oral Health will be evaluated using a single question which asks about overall health of participant's mouth, teeth, and gums. The scale ranges from 1 (excellent) to 6 (Very poor), where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

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

Effect on Life will be evaluated using 4 questions which asks how much the sensations in teeth affect participant's life overall. The scale ranges from 0 (not at all) to 4 (Very much), where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

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

The DHEQ consists of 5 domains namely- Restrictions, Adaptation, Social Impact, Emotional Impact and Identity with total 34 questions about the ways in which any sensations in teeth affect participants in their daily life. The scale ranges from 1(strongly disagree) to 7(strongly agree) and scores 5 to 7 indicates agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree.

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

NPRS is the 11-point segmented numeric version of a Visual Analogue Scale from which the respondent selects the score (0-10) that best reflects the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher scores are indicative of greater pain intensity. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.

Satisfaction Numeric Rating Scale (NRS) Score at Week 24

Participants will rate their satisfaction with the DH treatment using NRS. It is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the individual sought help from treatment. It ranges from 0 (completely dissatisfied) to 10 (completely satisfied), with higher scores indicative of greater satisfaction.

Oral Hygiene Questionnaire (OHQ) Responses at Baseline

Participants will describe their oral hygiene habits at Baseline by completion of an OHQ.

Full Information

NCT ID

NCT06045026

First Posted

September 13, 2023

Last Updated

October 6, 2023

Sponsor

HALEON

1. Study Identification

Unique Protocol Identification Number

NCT06045026

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 21, 2023 (Actual)

Primary Completion Date

May 17, 2024 (Anticipated)

Study Completion Date

May 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HALEON

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste). OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dentin Sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anti-sensitivity toothpaste

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Stannous fluoride

Intervention Description

Anti-sensitivity toothpaste containing 0.454% Stannous Fluoride

Primary Outcome Measure Information:

Title

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

Description

Time Frame