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.

NCT02651467 | Completed Results DMC

• 1 other identifier: 204763
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)

  Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 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 the stimulus.

  Baseline and Week 8

Secondary Outcomes (4)

• Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)

  Baseline and Week 8

• Change From Baseline in Schiff Sensitivity Score at Week 4

  Baseline and Week 4

• Change From Baseline in Tactile Threshold at Week 4 and 8

  Baseline, Week 4 and 8

• Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8

  Baseline, Week 4 and 8

Study Arms (3)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

PLACEBO COMPARATOR

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.

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

Interventions

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

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

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

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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: January 7, 2016
• First Posted: January 11, 2016
• Study Start: January 4, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 22, 2016
• Last Updated: August 27, 2018
• Results First Posted: March 9, 2017

Record last verified: 2018-07

Locations

US (1)