Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity

NCT02861664 | Completed Results

• 1 other identifier: 205794
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. The test and control dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score at Week 8

  The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 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 indicate improvement in sensitivity.

  At Baseline and Week 8

Secondary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score at Week 4

  At Baseline and Week 4

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

  At Baseline, Week 4 and Week 8

Study Arms (2)

Test Dentifrice: Stannous fluoride (SnF2)

EXPERIMENTAL

Participants were instructed to apply a strip of dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million \[ppm\] fluoride in total) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.

Other: Stannous fluoride (SnF2)

Negative Control Dentifrice: Sodium monofluorophosphate (SMFP)

ACTIVE COMPARATOR

Participants were instructed to apply a strip of dentifrice containing 1400ppm fluoride as sodium monofluorophosphate (SMFP) to cover the head of the toothbrush and brush their teeth for 1 timed minute, twice daily (morning and evening), following their normal routine. Participants were also permitted to rinse with tap water.

Other: Sodium monofluorophosphate (SMFP)

Interventions

Stannous fluoride (SnF2) OTHER

Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF

Test Dentifrice: Stannous fluoride (SnF2)

Sodium monofluorophosphate (SMFP) OTHER

Dentifrice containing 1400 ppm fluoride as SMFP

Negative Control Dentifrice: Sodium monofluorophosphate (SMFP)

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
• Aged between 18 and 65 years inclusive
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• 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 and 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.
• At Screening-
• Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 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, that meet all of the following criteria; signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR), tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Schiff sensitivity score ≥1).
• At Baseline (Visit 2)-
• Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria i.e.
• Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).

You may not qualify if:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Women who are breast-feeding.
• 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 and participation in another tooth desensitizing treatment study within 8 weeks of the screening visit.
• Recent history (within the last year) of alcohol or other substance abuse.
• An employee of the sponsor or the study site or members of their immediate family.
• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes, presence of a condition which, in the opinion of the investigator is causing xerostomia.
• Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants and 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 8 weeks of Screening.
• Desensitising treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments).
• a) Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening
• b) 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.
• C) Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator.
• Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (Participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients).
• Any subject who, in the judgment of the investigator, should not participate in the study, any condition which in the opinion of the investigator would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wuhan, 430079, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tin Fluorides; fluorophosphate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: September 21, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 24, 2016
• Last Updated: August 10, 2018
• Results First Posted: August 10, 2018

Record last verified: 2018-06

Locations

CN (1)