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

Not Applicable

Completed

• Conditions: Pain; Dentin Desensitizing Agents; Tooth Bleaching
• Interventions: Other: GP (Gel placebo); Other: EG (Experimental A. Oleracea extract gel)

• Registration Number: NCT05725850
• Lead Sponsor: Universidade Federal do Para

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-07
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-27
• Status Verified: 2023-02
• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-10
• Last Update Submitted: 2023-02-10
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP (Gel placebo)	GP (Gel placebo)	The GP group received the application of a placebo gel.
EG (Experimental A. Oleracea extract gel)	EG (Experimental A. Oleracea extract gel)	The EG group received the application of experimental gel of A. Oleracea extract for post tooth bleaching sensitivity.

Primary Outcome Measures

Name	Time	Method
Assessment of post bleaching sensitivity	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 a millimeter ruler, thus obtaining the patient's level of pain intensity.

Secondary Outcome Measures

Name	Time	Method
Color evaluation	Baseline (Ti) and one week after the 3rd whitening session (Tf).	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).

Trial Locations

Locations (1)

Federal University of Para; 🇧🇷 Belém, PA, Brazil