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

Not Applicable

Completed

Conditions: Dentin Sensitivity

Interventions: Other: Stannous fluoride

Registration Number: NCT06045026

Lead Sponsor: HALEON

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 536

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:
1. 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.
2. Participant with full or partial denture(s).
3. 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.
4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
5. Participant who has been informed by a DHCP that they have active caries.
6. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24	Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 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.
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24	Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 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).
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain (Section 2, Q5-16) Score at Weeks 4, 8, 12, 16, 20 and 24	Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 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).
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24	Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 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).
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24	Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 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).
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24	Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 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).

Secondary Outcome Measures

Name	Time	Method
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	DHEQ Section 1 included 3 questions about participant's sensitive teeth and its impact on everyday life. Participants scored 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 ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in intensity, botheration and tolerability of sensations.
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	Global Oral Health was evaluated using a single question of DHEQ. Participants rated the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicated better oral health. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in global oral health.
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	Effect on life was evaluated using 4 questions of DHEQ (Section 2, Q36-39) about how much the sensations in teeth affected participant's life overall. Participants scored each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranged from 0 to 16, where lower score indicated less effect of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall quality of life (less effect of sensations on participant's life overall).
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	The DHEQ is a condition-specific measure of OHrQoL in relation to 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(strongly disagree) to 7(strongly agree) where lower score indicated better quality of life in relation to DH. Scores 5 to 7 indicated agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree. Percentage of participants with scores 5 to 7 for each statement in the 5 DHEQ domains were reported.
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	NPRS was an 11-point segmented numeric version of a Visual Analogue Scale from which the participant selected a score from 0 to 10 that best reflected the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher scores indicated of greater pain intensity. Change from Baseline was calculated by subtracting the Baseline score from score at each indicated timepoint. A negative change from Baseline indicated improvement (reduction in pain intensity).
Satisfaction Numeric Rating Scale (NRS) Score at Week 24	Week 24	Participants were asked to rate their satisfaction with the DH treatment using NRS. NRS is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the participant sought help from treatment. The score ranged from 0 (completely dissatisfied) to 10 (completely satisfied), where higher scores indicated greater satisfaction with DH treatment.
Number of Participants With Oral Hygiene Questionnaire (OHQ) Responses at Baseline	Baseline (Week 0)	Participants described their oral hygiene habits by completion of an OHQ. It included 9 questions: Q1:How frequently do you normally brush your teeth? Q2:Have you had a professional or self-applied tooth whitening treatment in the last 2 weeks? Q3:Have you had a professional tooth cleaning in the last 2 weeks? Q4:Have you ever been diagnosed with sensitive teeth by a dentist? Q5: When was the last time you visited a dentist/hygienist? Q6:Do you use a toothpaste designed specifically for sensitive teeth? Q7:What brand of toothpaste do you most frequently use? Q8:What type of toothbrush do you use? Q9:Can you tell me if you have any of the following: Cracked tooth/ teeth Chipped tooth/teeth, Cold sores, Grinding teeth, Gum swelling/inflammation, Receding gums, Painful/tender gums when brushing, Ulcers in the mouth, Stained/yellow teeth, Seeing blood when you spit when you brush your teeth, Bad breath, None of these. Number of Participants with OHQ Responses at Baseline were reported.