Randomized Clinical Trial to Evaluate the Efficacy of Nano-hydroxyapatite Combined With the Potassium Nitrate for the Treatment of Dental Sensitivity
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment
Study Overview
Brief Summary
The chief aim of this study is to evaluate the difference in tooth sensitivity after having used a gel containing nano - hydroxyapatite and potassium nitrate
This randomized double-blind clinical study is designed to compare the efficacy in reducing dentin hypersensitivity of a toothpaste gel containing Nano-hydroxyapatite and potassium nitrate (Cavex Bite & White ExSense, Cavex Holland BV) with a fluoride-based gel toothpaste ( Colgate, Protection Caries, Palmolive SPA ).
Specific objectives :
To evaluate through standardized tests the dental sensitivity before and after the application of toothpastes; To compare the variations of dental sensitivity test and control groups.
Safety:
determination of adverse reactions, such as increased tooth pain and changes in the oral mucosa after application of the materials.
Detailed Description
Study Design
The study will be a clinical randomized double-blind trial monocentric.
The sample will be divided into three groups with 35 patients each one.
TREATMENTS NOT ALLOWED
Patients enrolled in the study should not be submitted, for the whole duration of the trial, to local and systemic treatments for dentine hypersensitivity.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients will be considered suitable for the study if they had sensitive teeth showing abrasion, erosion, or recession with the exposure of the cervical dentine.
Exclusion Criteria
- •Teeth with subjective or objective evidence of carious lesions, pulpitis, restorations, premature contact, cracked enamel, active periapical infection, or which had received periodontal surgery or root-planning up to 6 months prior to the investigation will be excluded from the study.
- •Professional desensitizing therapy during the previous 3 months, or use of desensitizing toothpaste in the last 6 weeks.
- •Patients will be also excluded if they will be under significant medication that could interfere with pain perception (e.g., antidepressants, anti-inflammatory drugs, sedatives, and muscle relaxants).
Outcomes
Primary Outcomes
Evaluation of change of baseline VAS score at 4 weeks, and 8 Weeks after the treatment
Time Frame: baseline, 4 weeks, and 8 weeks
The pain experience was assessed by a Visual Analogue Scale (VAS) using the methodology. The VAS scale consisted of a horizontal line that was 100 mm long, on which 'no pain' was marked on the right-hand extremity and 'unbearable pain' on the other. The patients expressed the intensity of the pain experienced by placing a mark at any point along the continuum. The distance, expressed in millimetres, from the right edge of 'no pain' was used as the VAS score. Each patient was asked to rate the perception of discomfort after the application of air via a dental syringe at 45-60 psi, 1 cm at the cervical third of the tooth after removing supragingival plaque with a low- speed handpiece with pumice powder and without fluoride. The adjacent teeth were covered by cotton rolls. The stimulus was delivered until reaction or up to a maximum duration of 10 s by the same examiner with the same equipment yielding similar air pressure each time.
Secondary Outcomes
No secondary outcomes reported
Investigators
Egle Milia
Prof
Università degli Studi di Sassari