Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

NCT02371616 | Completed Results

• 1 other identifier: 202199
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 3

Brief Summary

An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

Conditions

Dentine Sensitivity

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8

  Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.

  At Baseline and Week 8

Secondary Outcomes (3)

• Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4

  At Baseline and Week 4

• Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8

  At Baseline, Week 4 and Week 8

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

  At Baseline, Week 4 and Week 8

Study Arms (2)

Test dentifrice

EXPERIMENTAL

Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium flouride

Device: Calcium sodium phosphosilicate; Other: Sodium fluoride

Comparator dentifrice

ACTIVE COMPARATOR

Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate

Device: Calcium sodium phosphosilicate; Other: Sodium monofluorophosphate

Interventions

Calcium sodium phosphosilicate DEVICE

5% w/w calcium sodium phosphosilicate

Comparator dentifrice; Test dentifrice

Sodium fluoride OTHER

1426 ppm fluoride as sodium fluoride

Test dentifrice

Sodium monofluorophosphate OTHER

1426 ppm fluoride as sodium monofluorophosphate

Comparator dentifrice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• subjects in good general health with no clinically significant/ relevant abnormalities of 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) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
• 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:

• subjects 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+C60
• scaling or root planing 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 (3)

GSK Investigational Site

Ellesmere Port, Cheshire, CH65 4BW, United Kingdom

Location

GSK Investigational Site

Maldon, Essex, CM9 5PN, United Kingdom

Location

GSK Investigational Site

Metropolitan Borough of Wirral, CH41 6EY, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Sodium Fluoride; fluorophosphate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

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, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: February 25, 2015
• Study Start: September 29, 2014
• Primary Completion: December 18, 2014
• Study Completion: December 18, 2014
• Last Updated: April 4, 2018
• Results First Posted: February 26, 2018

Record last verified: 2017-12

Locations

GB (3)