A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.

NCT ID: NCT02651467

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-04
• Study Completion Date: 2016-04-22

Brief Summary

This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)

Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 1 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks.

Group Type: EXPERIMENTAL

Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)

Intervention Type: OTHER

1.5% w/w KOX, 0ppm F, pH 7.0

Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)

Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the experimental oral rinse 2 (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks.

Group Type: EXPERIMENTAL

Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)

Intervention Type: OTHER

2.0% w/w KOX, 45ppm F, pH 4.5

Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )

Participants will apply a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brush their teeth for one timed minute and expectorate. They will then rinse with 20ml of tap water (using the dosing cap provided) for 10 seconds and expectorate, then rinse with 10ml of the placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorate. No further rinsing will be allowed. This regimen will be performed twice daily for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )

Intervention Type: OTHER

0% w/w KOX 0ppm F, pH 4.5

Interventions

Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)

1.5% w/w KOX, 0ppm F, pH 7.0

Intervention Type: OTHER

Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)

2.0% w/w KOX, 45ppm F, pH 4.5

Intervention Type: OTHER

Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )

0% w/w KOX 0ppm F, pH 4.5

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Participants will be male or female aged between 18 and 65 years inclusive.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee.

No clinically significant and relevant abnormalities in medical history or upon oral examination.

Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

• Self-reported history of dentinal hypersensitivity (DH) lasting more than(>) six months but not > 10 years.
• Good general oral health, with a minimum of 20 natural teeth.
• Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.

Exclusion Criteria

• Women who are pregnant or breast-feeding .
• Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
• Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
• Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
• Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
• Any condition which, in the opinion of the investigator, causes xerostomia.
• 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 (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
• Previous participation in this study.
• Recent history (within the last year) of alcohol or other substance abuse.
• Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants.
• Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
• Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
• Teeth bleaching within eight weeks of Screening.
• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
• Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
• Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the Investigator.
• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening.
• Individuals who require antibiotic prophylaxis for dental procedures.
• Any participant who, in the judgment of the investigator, should not participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

204763

Identifier Type: -

Identifier Source: org_study_id