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Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

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ClinicalTrials.gov Identifier: NCT02773758
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : December 12, 2016
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Other: Stannous Fluoride Dentifrice Other: Sodium monofluorophosphate Dentifrice Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : March 11, 2016
Actual Study Completion Date : March 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Stannous Fluoride Dentifrice
Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water.
Other: Stannous Fluoride Dentifrice
Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)

Sodium monofluorophosphate Dentifrice
Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water.
Other: Sodium monofluorophosphate Dentifrice
Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)




Primary Outcome Measures :
  1. Change From Baseline in Schiff Sensitivity Score at Day 14 [ Time Frame: Baseline, Day 14 ]
    Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated 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.


Secondary Outcome Measures :
  1. Change From Baseline in Schiff Sensitivity Score at Day 7 [ Time Frame: Baseline, Day 7 ]
    Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated 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.

  2. Change From Baseline in Tactile Threshold at Day 7 and Day 14 [ Time Frame: Baseline, Day 7 and Day 14 ]
    A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • Aged 18-65 years inclusive.
  • Good general and mental health with:

No clinically significant and relevant abnormalities of medical history or oral examination.

Absence of any condition that would impact on the participant's safety or wellbeing 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 more than 10 years.
  • 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 at screening: 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.

Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes[Y]/No[N] response).

  • Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria at screening:

Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).

Exclusion Criteria:

  • Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Previous participation in this study or participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.
  • Dental prophylaxis within 4 weeks of Screening.
  • Tongue or lip piercing or presence of dental implants.
  • 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.
  • 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 dentifrice.
  • Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening.
  • 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 2 weeks of Baseline.
  • Daily dose of a medication which, in the opinion of the Investigator, is causing xerostomia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773758


Locations
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Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L4W 0C2
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02773758    
Other Study ID Numbers: 205201
First Posted: May 16, 2016    Key Record Dates
Results First Posted: December 12, 2016
Last Update Posted: September 29, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Fluorides
Tin Fluorides
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs