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NCT07741032

Overview

NCT ID: NCT07741032
Lead Sponsor: HALEONINDUSTRY
Official Title: A Proof of Concept Study to Evaluate the Efficacy of Two Experimental Mouthwash Formulations in the Relief of Dentinal Hypersensitivity
Brief Summary: The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily for the treatment of dentinal hypersensitivity.
Conditions: Dentine Hypersensitivity
Interventions: 3% KNO3 Mouthwash

Status and Timeline

Status: Completed
Last Update Posted: Aug 3, 2026Actual
Start Date: Mar 26, 2012Actual
Primary Completion Date: Jul 9, 2012Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Participant who demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

Participant understands and is willing, able and likely to comply with all study procedures and restrictions.

A participant with a minimum of 20 natural teeth and in good general health who suffer from tooth sensitivity.

At screening, participants with a minimum of four accessible nonadjacent teeth (incisors, canines, or pre-molars) with signs of facial/cervical gingival recession and/or signs of erosion or abrasion.

At screening, self-reported history of Dentinal Hypersensitivity lasting more than 6 months but not more than 10 years.

At Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria: - Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple less than or equal to [<=] 20 gram) and evaporative (air) assessment (Schiff Sensitivity Score greater than or equal to [>=] 2)

Exclusion Criteria:

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.

Women who are breastfeeding.

Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Participation in another clinical study or receipt of an investigational drug within 30 days of the Screening visit.

Participation in a desensitising treatment study within 8 weeks of the Screening visit.

Previous participation in this study.

Recent history (within the last year) of alcohol or other substance abuse.

An employee of the sponsor or the study site or members of their immediate family.

Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.

Dental prophylaxis within 4 weeks of Screening.

Tongue or lip piercing or presence of dental implants.

Desensitizing treatment within 8 weeks of Screening.

Teeth bleaching within 8 weeks of Screening.

Any participant who, in the judgment of the investigator, should not participate in the study.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 118Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: proDERM

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