Last updated: 11/07/2018 12:31:38
Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Trial description: An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in evaporative air sensitivity as measured by visual analogue score (VAS) at Week 8
Timeframe: At Baseline and Week 8
Secondary outcomes:
Mean change from baseline in evaporative air sensitivity as measured by visual analogue score (VAS) at Week 4
Timeframe: At Baseline and Week 4
Mean change from baseline in evaporative air sensitivity as measured by schiff sensitivity score at Week 4 and Week 8
Timeframe: At Baseline, Week 4 and Week 8
Change from baseline in tactile threshold at Week 4 and Week 8
Timeframe: At Baseline, Week 4 and Week 8
Interventions:
Device: Calcium sodium phosphosilicate
Other: Sodium fluoride
Other: Sodium monofluorophosphate
Enrollment:
304
Observational study model:
Not applicable
Primary completion date:
2014-18-12
Time perspective:
Not applicable
Clinical publications:
J Clin Dent 2017;27(4):97-104
Medical condition
Dentine Sensitivity
Product
GSK3413189, GSK3490073, SKF46656, calcium sodium phosphosilicate/sodium monofluorophosphate, sodium fluoride
Collaborators
Not applicable
Study date(s)
September 2014 to December 2014
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- subjects in good general health with no clinically significant/ relevant abnormalities of oral examination
- pre-existing self reported and clinically diagnosed tooth sensitivity
- subjects with a known or suspected intolerance or hypersensitivity to study products
- presence of chronic debilitating disease which could affect study outcomes
Inclusion and exclusion criteria
Inclusion criteria:
- subjects in good general health with no clinically significant/ relevant abnormalities of oral examination
- pre-existing self reported and clinically diagnosed tooth sensitivity
- at screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
- at baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)
Exclusion criteria:
- subjects with a known or suspected intolerance or hypersensitivity to study products
- presence of chronic debilitating disease which could affect study outcomes
- any condition which is causing dry mouth
- use of an oral care product indicated for the relief of dentine hypersensitivity
- participation in a DH treatment study in the 8 weeks prior to screening
- taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
- require antibiotic prophylaxis for dental procedures
- dental prophylaxis within 4 weeks of screening
- treatment of periodontal disease within 12 months of screening+C60
- scaling or root planing within 3 months of screening
- tooth bleaching within 8 weeks of screening
- active caries or periodontitis
- partial dentures, orthodontic appliances or dental implants which could affect study outcomes
- Pregnant and breast-feeding females
- Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth 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
Trial location(s)
Location
GSK Investigational Site
Maldon, Essex, United Kingdom, CM9 5PN
Status
Study Complete
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
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
2014-18-12
Actual study completion date
2014-18-12
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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