Evaluation of the Effect of na Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity: a Randomized Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tooth Bleaching Pain
- Sponsor
- Universidade Federal do Para
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Assessment of post-bleaching sensitivity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing copaiba oil resin in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into 3 different groups - GC (placebo); GN (potassium nitrate and sodium fluoride); GCO (copaiba oil resin). The dental elements of the GCO received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GC and GN groups also received the application of a placebo gel and a nitrate potassium and sodiun fluoride gel, respectively, under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
Investigators
Cecy Martins Silva
Professor of the graduate program in dentistry at Federal Univeersity of Pará
Universidade Federal do Para
Eligibility Criteria
Inclusion Criteria
- •good oral hygiene
- •absence of active caries lesions
- •never undergone bleaching therapy
- •not present dental hypersensitivity
- •don't be a smoker
- •don´t be pregnant
- •present at least 28 teeth in the oral cavity
Exclusion Criteria
- •volunteers undergoing orthodontic treatment,
- •presence of periodontal disease
- •dental cracks or fractures
- •restorations and prostheses on anterior teeth
- •extensive molar restorations
- •gastroesophageal disorders
- •severe internal dental darkening
- •presence of dentinal exposure in anterior and / or posterior teeth.
Outcomes
Primary Outcomes
Assessment of post-bleaching sensitivity
Time Frame: 21 days
For the assessment of postoperative sensitivity, patients were instructed to fill out a form to record tooth sensitivity daily, during the 21 days of treatment, based on individual pain perception. This form was delivered at each bleaching session, being returned to the researcher in the following session, that is, always one week after each bleaching session. The evaluation form consisted of the visual analogue scale (VAS). This scale consists of a 10 cm horizontal line, with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity. The patient was instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day. So that the distance in millimeters from the zero end could be later measured with the aid of amillimeter ruler, thus obtaining the patient's level of pain intensity.
Secondary Outcomes
- Color evaluation(Baseline (Ti) and one week after the 3rd bleaching session (Tf))