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The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity

Primary Purpose

Tooth Bleaching, Pain, Dentin Desensitizing Agents

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
EG (Experimental A. Oleracea extract gel)
GP (Gel placebo)
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

Eligibility Criteria

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

Inclusion Criteria: good oral hygiene absence of active caries lesions never having undergone previous whitening therapy not present dental hypersensitivity don't be a smoker not be pregnant present at least 28 teeth in the oral cavity. Exclusion Criteria: volunteers who were under 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 Type

Experimental

Placebo Comparator

Arm Label

EG (Experimental A. Oleracea extract gel)

GP (Gel placebo)

Arm Description

The EG group received the application of experimental gel of A. Oleracea extract for post tooth bleaching sensitivity.

The GP group received the application of a placebo gel.

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 a millimeter 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
February 2, 2023
Last Updated
February 10, 2023
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT05725850
Brief Title
The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity
Official Title
Evaluation of the Effect of an Experimental Gel Based on Jambu Extract ( Acmella Oleracea) in Reducing Post-bleaching Tooth Sensitivity : a Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
December 27, 2022 (Actual)

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 10% jambu extract (Acmella Oleracea) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into two different groups - GE (A. Oleracea extract at 10%) and GP (placebo). The dental elements of the GE 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 GP group also received the application of a placebo gel (without active ingredient), 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, Dentin Desensitizing Agents

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
EG (Experimental A. Oleracea extract gel)
Arm Type
Experimental
Arm Description
The EG group received the application of experimental gel of A. Oleracea extract for post tooth bleaching sensitivity.
Arm Title
GP (Gel placebo)
Arm Type
Placebo Comparator
Arm Description
The GP group received the application of a placebo gel.
Intervention Type
Other
Intervention Name(s)
EG (Experimental A. Oleracea extract gel)
Intervention Description
Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the EG 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.
Intervention Type
Other
Intervention Name(s)
GP (Gel placebo)
Intervention Description
Prior to bleaching treatment with 35% hydrogen peroxide, the GP group also received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
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 a millimeter 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 whitening 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 having undergone previous whitening therapy not present dental hypersensitivity don't be a smoker not be pregnant present at least 28 teeth in the oral cavity. Exclusion Criteria: volunteers who were under 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

12. IPD Sharing Statement

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The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity

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