N/A
N=304
Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity
Dentine Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02371616 ↗Enrolled (actual)
304
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 — 53.05; 55.89; 31.62; 30.51 score on a scale — p=0.2678
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calcium sodium phosphosilicate (Device); Sodium fluoride (Other); Sodium monofluorophosphate (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8 |
53.05; 55.89; 31.62; 30.51; -21.50; -25.16 | 0.2678 |
| SECONDARY Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4 |
40.71; 40.60; -12.12; -15.24 | — |
| SECONDARY Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8 |
2.72; 2.68; 2.13; 2.11; -0.59; -0.57 | — |
| SECONDARY Change From Baseline in Tactile Threshold at Week 4 and Week 8 |
12.79; 12.18; 25.45; 23.61; 12.72; 11.42 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02371616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.