A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.

NCT02753075 | Completed Results

• 1 other identifier: 204773
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8

  The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.

  Baseline, Week 8

Secondary Outcomes (6)

• Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8

  Baseline, Week 8

• Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4

  Baseline, Week 4

• Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4

  Baseline, Week 4

• Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8

  Baseline, Week 8

• Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4

  Baseline, Week 4

Study Arms (3)

Experimental Oral Rinse 1

EXPERIMENTAL

Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Device: Experimental Oral Rinse 1; Drug: Fluoride toothpaste

Experimental Oral Rinse 2

EXPERIMENTAL

Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Device: Experimental Oral Rinse 2; Drug: Fluoride toothpaste

Placebo Oral Rinse

PLACEBO COMPARATOR

Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Other: Placebo Oral Rinse; Drug: Fluoride toothpaste

Interventions

Experimental Oral Rinse 1 DEVICE

Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5

Experimental Oral Rinse 1

Experimental Oral Rinse 2 DEVICE

Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5

Experimental Oral Rinse 2

Placebo Oral Rinse OTHER

Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5

Placebo Oral Rinse

Fluoride toothpaste DRUG

Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

Experimental Oral Rinse 1; Experimental Oral Rinse 2; Placebo Oral Rinse

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination
• Pre-existing self reported and clinically diagnosed tooth sensitivity
• At screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
• At baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)

You may not qualify if:

• Participants with a known or suspected intolerance or hypersensitivity to study products
• Presence of chronic debilitating disease which could affect study outcomes
• Any condition which is causing dry mouth
• Use of an oral care product indicated for the relief of dentine hypersensitivity
• Participation in a DH treatment study in the 8 weeks prior to screening
• Taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
• Require antibiotic prophylaxis for dental procedures
• Dental prophylaxis within 4 weeks of screening
• Treatment of periodontal disease within 12 months of screening
• Scaling or root planning within 3 months of screening
• Tooth bleaching within 8 weeks of screening
• Active caries or periodontitis
• Partial dentures, orthodontic appliances or dental implants which could affect study outcomes
• Pregnant and breast-feeding females

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 27, 2016
• Study Start: September 8, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 18, 2015
• Last Updated: August 27, 2018
• Results First Posted: March 6, 2017

Record last verified: 2018-07

Locations

US (1)