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

Primary Purpose

Tooth Bleaching Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
GCO (Experimental copaiba oil resin gel)
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Bleaching Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Para

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

GCO (Experimental copaiba oil resin gel)

GN (Potassiun nitrate and sodium fluoride gel)

GC

Arm Description

The GCO group will receive the application of an experimental gel based on copaiba oil resin for post tooth bleaching sensitivity

The GN group will receive the application of a potassium and sodium nitrate gel for post tooth bleaching sensitivity

The GC group will receive the application of a placebo gel for post tooth bleaching sensitivity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
September 27, 2023
Last Updated
October 14, 2023
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT06066671
Brief Title
The Effect of an Experimental Gel Based on Copaiba Oil Resin in Reducing Post-bleaching Tooth Sensitivity
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 10, 2024 (Anticipated)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Bleaching Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GCO (Experimental copaiba oil resin gel)
Arm Type
Experimental
Arm Description
The GCO group will receive the application of an experimental gel based on copaiba oil resin for post tooth bleaching sensitivity
Arm Title
GN (Potassiun nitrate and sodium fluoride gel)
Arm Type
Active Comparator
Arm Description
The GN group will receive the application of a potassium and sodium nitrate gel for post tooth bleaching sensitivity
Arm Title
GC
Arm Type
Placebo Comparator
Arm Description
The GC group will receive the application of a placebo gel for post tooth bleaching sensitivity
Intervention Type
Other
Intervention Name(s)
GCO (Experimental copaiba oil resin gel)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of post-bleaching sensitivity
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Color evaluation
Description
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).
Time Frame
Baseline (Ti) and one week after the 3rd bleaching session (Tf)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Federal University of Para
City
Belém
State/Province
PA
ZIP/Postal Code
66075-110
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecy Silva, PhD
Phone
5591991144905
Email
cecymsilva@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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