A Study Evaluating Oral-Health-Related Quality of Life and Treatment Patterns Among Dentin Hypersensitivity Sufferers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHALEON

About this trial

The primary purpose of this study is to characterize changes in Oral-Health-Related Quality of Life (OHrQoL), as measured by the Dentin Hypersensitivity Experience Questionnaire (DHEQ) over a 12-month period.

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 more than or equal to (>=)18 years.

Anyone who has begun to experience dentin hypersensitivity (self-reported) within the past three months.

Anyone who has started to use products to treat their tooth sensitivity within the past three months.

Disqualifiers

Anyone who has any chronic health conditions that could impact their participation in this study, such as cancer, mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.

Anyone who suffers from tooth cavities, significant gum disease, cracked or fractured teeth, temporomandibular joint disease (TMD), or who has had tooth extractions or fillings within the last three months.

Anyone who wears braces (including Invisalign-like appliances) for treatment or dentures (full or partial).

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.

Trial population

Participants who are new sufferers of DH and have begun treating their DH.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

375 Participants
are grouped into 1 trial group
Group A: New sufferers of self-reported Dentin Hypersensitivity aged 18+ years

Trial outcomes

Primary outcomes

1

Change From Baseline in Total DHEQ Score Over 12 Months

Change from baseline in total DHEQ score and each of the domain scores (daily restrictions, coping behaviors, personal identity, social impact, emotional impact) over 12 months. The DHEQ has total 15 questions each will be scored on a scale ranging from 1 (strongly disagree) to 7 (strongly agree), thus total possible score will be ranging from 15 to 105, where higher score indicates worst outcome.

Time frame
Baseline and up to 12 Months

Secondary outcomes

1

Description of Treatment Selection Over 12 Months

Participants will select the appropriate options from the given list of products. Data will be summarized using descriptive statistics.

Time frame
Up to 12 Months
2

Treatment Discontinuation/Switch Over 12 Months

Participant will respond to the question either as Yes or No. Data will be summarized using descriptive statistics.

Time frame
Up to 12 Months
3

Frequency of Treatment Used Over 12 Months

Participants will select the appropriate frequency options from the given list. Data will be summarized using descriptive statistics.

Time frame
Up to 12 Months
4

Frequency of DH Over 12 Months

Participants will select the appropriate frequency options from the given list. Data will be summarized using descriptive statistics.

Time frame
Up to 12 Months

Other outcomes

Sponsors and contacts

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