Last updated: 11/04/2018 13:50:51
Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief from Dentinal Hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief from Dentinal Hypersensitivity
Trial description: A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Adjusted mean change from baseline in tooth hypersensivity to air stimuli immediately following treatment
Timeframe: Baseline and immediately after treatment administration
Secondary outcomes:
Adjusted mean change from baseline in tooth hypersensitivity to air stimuli at Day 3
Timeframe: Baseline and Day 3
Adjusted mean change from baseline in tooth hypersensitivity to air Stimuli at Day 14
Timeframe: Baseline and Day 14
Adjusted mean change from baseline in tooth hypersensitity to touch stimuli (Tactile) immediately after treatment
Timeframe: Baseline and immediately after treatment administration
Adjusted mean change from baseline in tooth hypersensitity to touch stimuli (Tactile) immediately at Day 3
Timeframe: Baseline and Day 3
Adjusted mean change from baseline in tooth hypersensitity to touch Stimuli (Tactile) immediately at Day 14
Timeframe: Baseline and Day 14
Interventions:
Drug: Test Toothpaste
Drug: Negative Control Toothpaste
Enrollment:
118
Observational study model:
Not applicable
Primary completion date:
2011-30-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentinal sensitivity, Hypersensitivity
Product
fluoride
Collaborators
Not applicable
Study date(s)
September 2011 to September 2011
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Inclusion:
- Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion: -Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years -Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. -Teeth having a gingival index score of less than or equal to 1 -Teeth with a clinical mobility less than or equal to 1 -sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2). Exclusion: -Presence of chronic debilitating disease which could affect study outcomes. -Any condition which causes xerostomia. -Dental prophylaxis within 4 weeks of screening. -Tongue or lip piercing or presence of dental implants. -Professional desensitising treatment within 12 weeks of screening. -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 12 weeks of screening. -Tooth with evidence of current or recent caries, or reported treatment of decay in 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, or not expected to respond to treatment with an over-the counter dentifrice. -Daily doses of a medication which could interfere with the perception of pain. -Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline. -Individuals who require antibiotic prophylaxis for dental procedures.
Trial location(s)
Location
BioSci Research America, Inc.
Las Vegas, NV, United States, 89121
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-30-09
Actual study completion date
2011-30-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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