Last updated: 08/05/2021 05:20:08
Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dentinal Hypersensitivity
Trial description: 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 astandard fluoride dentifrice.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Schiff sensitivity score on Day 14
Timeframe: Baseline, Day 14
Secondary outcomes:
Change from baseline in Schiff sensitivity score on Day 7
Timeframe: Baseline, Day 7
Change from baseline in tactile threshold on Day 7 and 14
Timeframe: Baseline, Day 7 and Day 14
Interventions:
Other: 0.454% w/w stannous fluoride (1100ppm fluoride)
Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)
Enrollment:
409
Observational study model:
Not applicable
Primary completion date:
2016-20-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentin Sensitivity
Product
sodium monofluorophosphate, stannous fluoride
Collaborators
Not applicable
Study date(s)
March 2016 to May 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Ellesmere Port, Cheshire, United Kingdom, CH65 4BW
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
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
2016-20-05
Actual study completion date
2016-20-05
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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