Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity

NCT02705716 | Completed Results

• 1 other identifier: 205212
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 3

Brief Summary

This study will investigate the efficacy of an experimental dentifrice containing 0.454% weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score on Day 14

  Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

  Baseline, Day 14

Secondary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score on Day 7

  Baseline, Day 7

• Change From Baseline in Tactile Threshold on Day 7 and 14

  Baseline, Day 7 and Day 14

Study Arms (2)

Test Dentifrice

EXPERIMENTAL

Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \[ppm\] fluoride). Participants will then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute.

Other: 0.454% w/w stannous fluoride (1100ppm fluoride)

Control Dentifrice

PLACEBO COMPARATOR

Participants will be instructed to apply a full brush head of toothpaste containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants will then brush the whole mouth thoroughly for at least 1 minute.

Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)

Interventions

0.454% w/w stannous fluoride (1100ppm fluoride) OTHER

Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)

Test Dentifrice

0.76% sodium monofluorophosphate (1000ppm fluoride) OTHER

Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Control Dentifrice

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.
• Participant is 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 well being 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 (3)

GSK Investigational Site

Ellesmere Port, Cheshire, CH65 4BW, United Kingdom

Location

GSK Investigational Site

Manchester, M16 9HQ, United Kingdom

Location

GSK Investigational Site

Metropolitan Borough of Wirral, CH41 6EY, United Kingdom

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

fluorophosphate

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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: May 20, 2016
• Study Completion: May 20, 2016
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-04

Locations

GB (3)