Last updated: 11/07/2018 12:36:26
Efficacy of Two Experimental Oral rinses in Providing Long Term Relief from Dentinal Hypersensitivity
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 study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 against a Placebo Oral Rinse at Week 8
Timeframe: Baseline, Week 8
Secondary outcomes:
Change from Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
Timeframe: Baseline, Week 8
Change from Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Timeframe: Baseline, Week 4
Change from Baseline in Tactile Threshold (gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
Timeframe: Baseline, Week 4
Change from Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8
Timeframe: Baseline, Week 8
Change from Baseline in Visual Rating Scale (VRS) of two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
Timeframe: Baseline, Week 4
Change from Baseline in VRS of two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
Timeframe: Baseline, Week 8
Interventions:
Device: Experimental Oral Rinse 1
Device: Experimental Oral Rinse 2
Other: Placebo Oral Rinse
Drug: Standard fluoride toothpaste
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
2015-18-12
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)
September 2015 to December 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 55 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
- Aged between 18 and 55 years inclusive
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
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
- Aged between 18 and 55 years inclusive
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: A. No clinically significant and relevant abnormalities in medical history or upon oral examination. B. Absence of any condition that would impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- Dental health At Screening: A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. B. Good general oral health, with a minimum of 20 natural teeth. C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
- Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
- Tooth with modified gingival index (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 (Y/N response). At Baseline: D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), 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)
Exclusion criteria:
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
- 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.
- Treatment of periodontal disease within 12 months of screening
- 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.
- 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
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
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
2015-18-12
Actual study completion date
2015-18-12
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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