The Effect of an Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity

Study 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).

Official Title
-----------------
Evaluation of the Effect of na Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity: a Randomized Clinical Study

Conditions
-----------------
Tooth Bleaching Pain

Intervention / Treatment
-----------------
* Other: GCO (Experimental copaiba oil resin gel)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GCO (Experimental copaiba oil resin gel)<br>The GCO group will receive the application of an experimental gel based on copaiba oil resin for post tooth bleaching sensitivity | Other: GCO (Experimental copaiba oil resin gel)<br>* Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the 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.<br>|
| Active Comparator: GN (Potassiun nitrate and sodium fluoride gel)<br>The GN group will receive the application of a potassium and sodium nitrate gel for post tooth bleaching sensitivity | Other: GCO (Experimental copaiba oil resin gel)<br>* Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the 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.<br>|
| Placebo Comparator: GC<br>The GC group will receive the application of a placebo gel for post tooth bleaching sensitivity | Other: GCO (Experimental copaiba oil resin gel)<br>* Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the GCO will receive the 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of post-bleaching sensitivity | 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. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color evaluation | The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) was used to measure the color, where the area of dental correspondence to be evaluated was the middle third of the buccal surface of the upper canines. To standardize the color readings, silicone trays were made, where the impression was extended from canine to canine. A window was created on the buccal surface of each canine of the silicone guide using a metal device with a 6 mm radius, corresponding to the diameter of the spectrophotometer tip. Thus, the tip of the device was inserted into the silicone guide to obtain the color parameters. Subsequently, the color difference between baseline (T i) and one week after the 3rd bleaching session (T f ) was calculated using the CIEDE2000 formulas (ΔE00). | Baseline (Ti) and one week after the 3rd bleaching session (Tf) |