Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

NCT01831817 | Completed Phase 2 Results

• 1 other identifier: RH01591
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Conditions

Dentinal Hypersensitivity

Outcome Measures

Primary Outcomes (6)

• Mean Change From Baseline in Schiff Sensitivity Score at Week 4

  Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.

  Baseline and 4 weeks post administration of study treatment

• Mean Change From Baseline in Schiff Sensitivity Score at Week 8

  Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.

  Baseline and 8 weeks post administration of study treatment

• Median Change From Baseline in Tactile Sensitivity at Week 4

  Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.

  Baseline and 4 weeks post administration of study treatment

• Median Change From Baseline in Tactile Sensitivity at Week 8

  Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.

  Baseline and 8 weeks post administration of study treatment

• Mean Change From Baseline in Visual Rating Scale Score at Week 4

  The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".

  Baseline and 4 weeks post administration of study treatment

• Mean Change From Baseline in Visual Rating Scale Score at Week 8

  The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".

  Baseline and 8 weeks post administration of study treatment

Secondary Outcomes (2)

• Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4

  Baseline and 4 weeks post administration of study treatment

• Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8

  Baseline and 8 weeks post administration of study treatment

Study Arms (4)

5% calcium sodium phosphosilicate/ sodium monofluorophosphate

EXPERIMENTAL

Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

0% calcium sodium phosphosilicate/sodium monofluorophosphate

ACTIVE COMPARATOR

Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

Sodium monofluorophosphate

ACTIVE COMPARATOR

Dentifrice containing 1000 ppmF as sodium monofluorophosphate

Drug: Sodium monofluorophosphate dentifrice

Sodium fluoride

ACTIVE COMPARATOR

Dentifrice containing 1100 ppmF as sodium fluoride

Drug: Sodium Fluoride dentifrice

Interventions

5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice DRUG

Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate

5% calcium sodium phosphosilicate/ sodium monofluorophosphate

0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice DRUG

No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate

0% calcium sodium phosphosilicate/sodium monofluorophosphate

Sodium monofluorophosphate dentifrice DRUG

Sodium monofluorophospate dentifrice (1000 ppm F)

Sodium monofluorophosphate

Sodium Fluoride dentifrice DRUG

Dentifrice containing 1100ppm F as sodium fluoride

Sodium fluoride

Eligibility Criteria

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

You may qualify if:

• Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
• Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.

You may not qualify if:

• Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
• Tooth with exposed dentin 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 etiologies other than erosion, abrasion or recession of exposed dentin.
• Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
• Use of a sensitivity dentifrice within 8 weeks of screening
• Individuals who require antibiotic prophylaxis for dental procedures

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

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: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 15, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 26, 2015
• Results First Posted: March 26, 2015

Record last verified: 2015-02

Locations

US (1)