Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity

NCT ID: NCT02705716

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2016-05-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test Dentifrice

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Control Dentifrice

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.

Group Type: PLACEBO_COMPARATOR

0.76% sodium monofluorophosphate (1000ppm fluoride)

Intervention Type: OTHER

Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Interventions

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

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

Intervention Type: OTHER

0.76% sodium monofluorophosphate (1000ppm fluoride)

Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
• Tooth with exposed dentine 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 aetiologies other than erosion, abrasion or recession of exposed dentine.
• Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the Investigator.
• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening.
• Individuals who require antibiotic prophylaxis for dental procedures.
• Any participant who, in the judgment of the investigator, should not participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ellesmere Port, Cheshire, United Kingdom

GSK Investigational Site

Manchester, , United Kingdom

GSK Investigational Site

Metropolitan Borough of Wirral, , United Kingdom

Countries

United Kingdom

Other Identifiers

205212

Identifier Type: -

Identifier Source: org_study_id