Last updated: 11/07/2018 12:36:45
A study to investigate efficacy of two experimental oral rinses in providing long term relief from pain derived from exposed dentine in response to chemical, thermal, tactile, or osmotic stimuli.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study Investigating the Efficacy of Two Experimental Oral rinses in Providing Long Term Relief from Dentinal Hypersensitivity
Trial description: This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 versus [vs.] Placebo)
Timeframe: Baseline and Week 8
Secondary outcomes:
Change from Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)
Timeframe: Baseline and Week 8
Change from baseline in Schiff Sensitivity Score at Week 4
Timeframe: Baseline and Week 4
Change from baseline in tactile threshold at Week 4 and 8
Timeframe: Baseline, Week 4 and 8
Change from baseline in Visual Rating scale (VRS) at Week 4 and 8
Timeframe: Baseline, Week 4 and 8
Interventions:
Other: Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)
Other: Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)
Other: Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
Enrollment:
221
Observational study model:
Not applicable
Primary completion date:
2016-22-04
Time perspective:
Not applicable
Clinical publications:
https://doi.org/10.1016/j.jdent.2017.12.004
Medical condition
Dentin Sensitivity
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2016 to April 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.
- Participants will be 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 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 > 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
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2016-22-04
Actual study completion date
2016-22-04
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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