Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity - Full Text View

Purpose

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.

Condition	Intervention	Phase
Dentine Hypersensitivity	Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice Drug: 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice Drug: Sodium monofluorophosphate dentifrice Drug: Sodium fluoride dentifrice	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity

Resource links provided by NLM:

MedlinePlus related topics: Allergy Calcium

Drug Information available for: Calcium Gluconate Sodium monofluorophosphate Sodium fluoride Fluorine Fluoride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Adjusted mean change from baseline in evaporative air sensitivity pain response on a Schiff sensitivity scale [ Time Frame: Baseline, 4 weeks and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
Response to a constant jet of air applied to hypersensitive teeth is 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 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Adjusted mean change from baseline in tactile sensitivity pain response [ Time Frame: Baseline, 4 weeks and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
Response to increasing force on hypersensitive teeth is evaluated using a Yeaple Probe pain response scale. According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.
Adjusted mean change from baseline in evaporative air sensitivity response on a Visual Rating Scale [ Time Frame: Baseline, 4 weeks and 8 weeks post administration of study treatment ] [ Designated as safety issue: No ]
Participants will rate the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).

Enrollment:	140
Study Start Date:	August 2012
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 5% calcium sodium phosphosilicate/sodium monofluorophosphate Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF).	Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Active Comparator: 0% calcium sodium phosphosilicate/sodium monofluorophosphate Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate	Drug: 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Active Comparator: Sodium monofluorophosphate Dentifrice containing 1000 ppmF as sodium monofluorophosphate	Drug: Sodium monofluorophosphate dentifrice Dentifrice containing 1000 ppmF as sodium monofluorophosphate
Active Comparator: Sodium fluoride Dentifrice containing 1100 ppmF as sodium fluoride	Drug: Sodium fluoride dentifrice Dentifrice containing 1100 ppmF as sodium fluoride

Detailed Description:

This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Breast-feeding: Women who are breast-feeding.
Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc.
Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs.
Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit b) Previous participation in this study.
Other: Any subject who in the opinion of the investigator, should not participate in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691560

Locations

United States, Nevada
BioSci Research America
Las Vegas, Nevada, United States, 89121-5466

Sponsors and Collaborators

GlaxoSmithKline

BioSci Research

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01691560 History of Changes
Other Study ID Numbers:	RH01426
Study First Received:	September 20, 2012
Last Updated:	April 18, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dentin Sensitivity
Hypersensitivity
Tooth Diseases
Stomatognathic Diseases
Immune System Diseases
Calcium, Dietary
Fluorides

Sodium Fluoride
Fluorophosphate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cariostatic Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013