Real-World Study of a Calcium Sodium Phosphosilicate Anti-Sensitivity Toothpaste for Dentin Hypersensitivity Relief

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHALEON

About this trial

The aim of this study is to evaluate the impact of a commercially available desensitizing dentifrice containing 5 percent (%) Calcium sodium phosphosilicate (CSPS) on oral health related quality of life (OHrQoL) in a DH (Dentin Hypersensitivity) population in a real-world setting.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 18 to 65.

Participant who is able to independently complete all activities on their smart devices

Participant who has tooth sensitivity (self-reported symptoms).

Disqualifiers

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.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Calcium sodium phosphosilicate (CSPS) Toothpaste

    Other intervention

    A toothpaste containing 5% weight/weight (w/w) calcium sodium phosphosilicate.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Test ToothpasteOther 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in DHEQ Total Score at Week 24

The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). 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 will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at Week 24.

Time frame
Baseline and Week 24

Secondary outcomes

1

Change From Baseline in DHEQ Restrictions Domain Score at Week 24

Restrictions domain of DHEQ evaluates 'the ways in which any sensations in teeth affects participants in their daily life'. It includes 4 questions, each will be scored using 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, resulting in a total score ranging from 4 to 28. A lower score indicates that sensations have less effect on daily life. Changes from a baseline will be calculated by subtracting the baseline score from the score at Week 24.

Time frame
Baseline and Week 24
2

Change From Baseline in DHEQ Adaptation Domain Score at Week 24

Adaptation domain of DHEQ evaluates 'the ways in which the sensations in teeth forces participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. It includes 12 questions, each will be 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 ranges from 12 to 84, where lower score indicates less effect of sensations on participant's daily life. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

Time frame
Baseline and Week 24
3

Change From Baseline in DHEQ Social Impact Domain Score at Week 24

Social Impact domain of DHEQ assesses how sensations affect participants in social situations. It includes 5 questions each will be 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. The total score ranges from 5 to 35. A lower score indicates less effect of sensations on participant's social life. Change from baseline is calculated by subtracting the baseline score from score at Week 24.

Time frame
Baseline and Week 24
4

Change From Baseline in DHEQ Emotional Impact Domain Score at Week 24

Emotional Impact Domain of DHEQ is used to assess the emotional impact of sensations in participant's teeth. It includes 8 questions each will be 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. The total score ranges from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline will be calculated by subtracting the Baseline score from score at Week 24.

Time frame
Baseline and Week 24

Other outcomes

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