A Study to Evaluate the Dentinal Hypersensitivity Efficacy of Two Experimental Mouthwash Formulations

NCT07741032 | Completed

• 1 other identifier: RH01474
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8

  Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.

  Baseline, Weeks 4, 6 and 8

• Change From Baseline in Tactile Threshold at Weeks 4, 6 and 8

  Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram. An increase in tactile threshold (gram) indicates improvement. Change from Baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.

  Baseline, Weeks 4, 6 and 8

Secondary Outcomes (4)

• Change From Baseline in Individual Questions Score from Dentine Hypersensitivity Experience Questionnaire (DHEQ) at Weeks 4 and 8

  Baseline, Weeks 4 and 8

• Change From Baseline in DHEQ Total Score at Week 4 and 8

  Baseline, Weeks 4 and 8

• Change From Baseline in Global Oral Health Score at Week 4 and 8

  Baseline, Weeks 4 and 8

• Change From Baseline in Effect on Life Overall Score at Week 4 and 8

  Baseline, Weeks 4 and 8

Study Arms (4)

3% KNO3 Mouthwash Twice Daily

EXPERIMENTAL

After brushing the teeth for 1 timed minute followed by rinsing with 10 milliliter (ml) potable water for 5 seconds, participants will be instructed to swish with 10ml of 3 percent (%) potassium nitrate (KNO3) Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks.

Other: 3% KNO3 Mouthwash

3% KNO3 Mouthwash Once Daily

EXPERIMENTAL

After brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 3% KNO3 Mouthwash for 1 timed minute once daily (morning only) for 8 Weeks.

Other: 3% KNO3 Mouthwash

2% HPC Mouthwash Twice Daily

EXPERIMENTAL

After brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 2% hydroxypropyl cellulose (HPC) Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks.

Other: 2% HPC Mouthwash

0% KNO3 Mouthwash Twice Daily

PLACEBO COMPARATOR

After brushing the teeth for 1 timed minute followed by rinsing with 10ml potable water for 5 seconds, participants will be instructed to swish with 10ml of 0% KNO3 Mouthwash for 1 timed minute twice daily (morning and evening) for 8 Weeks.

Other: 0% KNO3 Mouthwash

Interventions

3% KNO3 Mouthwash OTHER

3.0% weight by weight (w/w) KNO3 with 217 parts per million (ppm) sodium fluoride.

3% KNO3 Mouthwash Once Daily; 3% KNO3 Mouthwash Twice Daily

2% HPC Mouthwash OTHER

2.0% w/w HPC mouthwash with 217ppm sodium fluoride.

2% HPC Mouthwash Twice Daily

0% KNO3 Mouthwash OTHER

0% w/w KNO3 with 217ppm sodium fluoride.

0% KNO3 Mouthwash Twice Daily

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

proDERM

Harburg, Free and Hanseatic City of Hamburg, Germany

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: March 26, 2012
• Primary Completion: July 9, 2012
• Study Completion: July 9, 2012
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (1)