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

NCT ID: NCT05725850

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2022-12-27

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).

Conditions

Tooth Bleaching; Pain; Dentin Desensitizing Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EG (Experimental A. Oleracea extract gel)

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

Group Type: EXPERIMENTAL

EG (Experimental A. Oleracea extract gel)

Intervention Type: OTHER

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.

GP (Gel placebo)

The GP group received the application of a placebo gel.

Group Type: PLACEBO_COMPARATOR

GP (Gel placebo)

Intervention Type: OTHER

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.

Interventions

EG (Experimental A. Oleracea extract gel)

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

GP (Gel placebo)

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Para

OTHER

Sponsor Role: lead

Responsible Party

Cecy Martins Silva

Professor of the Graduate Program in Dentistry at the Federal University of Pará

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Para

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

UFPara-015

Identifier Type: -

Identifier Source: org_study_id