Last updated: 07/02/2019 10:00:23
To evaluate the efficacy of an experimental dissolvable strip in rapidly relieving dentinal hypersensitivity (DH)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A proof-of-principle clinical study investigating the efficacy of a dissolvable strip in providing rapid relief from dentinal hypersensitivity.
Trial description: A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Schiff sensitivity score after 10 minutes
Timeframe: At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study
Secondary outcomes:
Change from baseline in Schiff sensitivity score after 2 and 4 hours
Timeframe: At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study
Change from baseline in tactile threshold after 10 minutes, 2 hours and 4 hours
Timeframe: At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Change from baseline in numerical rating scale (NRS) scores after 10 minutes, 2 hours and 4 hours
Timeframe: At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study
Interventions:
Device: Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)
Enrollment:
126
Observational study model:
Not applicable
Primary completion date:
2016-22-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentin Sensitivity
Product
GSK3413189, sodium fluoride
Collaborators
Not applicable
Study date(s)
November 2016 to December 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 assigned and dated copy of the informed consent form.
- Aged 18-65 years.
- A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- A women who is breast-feeding.
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 assigned and dated copy of the informed consent form.
- Aged 18-65 years.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral Examination and absence of any condition that would impact on the participants safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- At Visit 1 (Screening): a) Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), in different quadrants and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Signs of facial/ cervical (i.e. labial/ buccal) 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 (Y/N response) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
- At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) in different quadrants of the mouth and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
Exclusion criteria:
- A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- A women who is 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 and previous participation in this study.
- 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 and any condition which, in the opinion of the investigator, causes xerostomia (dry mouth).
- Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice 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 and 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 and tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, dental implants, 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 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).
- 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 and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
- Any participant who, in the judgment of the investigator, should not participate in the study.
Trial location(s)
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89146
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
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
2016-22-12
Actual study completion date
2016-22-12
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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