Effect of Andiroba on Control of Post-whitening Tooth Sensitivity

NCT ID: NCT06614764

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2024-11-30

Brief Summary

This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. Volunteers in this study will be randomized into 3 different groups - PG (placebo gel), KF2G (potassium nitrate gel) and AG (andiroba gel). Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. This will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. Group GP will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. Subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (VAS). Color measurement will be performed with a spectrophotometer at two times: baseline (T0) and one week after the 3rd bleaching session (T1).

Detailed Description

All groups will undergo in-office whitening treatment, carried out in 3 sessions with a 7-day interval, according to the steps described below:

Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 15 minutes each, totaling 45 minutes; Final removal of the whitening gel and gingival barrier, followed by rinsing with water.

The application of the desensitizing agent or its placebo will follow this sequence:

Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.

Conditions

Tooth Bleaching; Pain; Dentin Desensitizing Agents

Study Design

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

Study Groups

PG- Placebo gel

The PG group received the application of placebo gel for post tooth bleaching sensitivity.

Group Type: PLACEBO_COMPARATOR

PG (Placebo Gel)

Intervention Type: OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the PG group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.

GKF2- Potassium nitrate

The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.

Group Type: ACTIVE_COMPARATOR

KF2G (Potassium nitrate gel)

Intervention Type: OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2G received application of the potassium nitrate 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.

AG- Andiroba Gel

The AG group received the application of experimental gel of andiroba (Carapa guianensis) for post tooth bleaching sensitivity.

Group Type: EXPERIMENTAL

AG (experimental Andiroba Gel)

Intervention Type: OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the AG 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.

Interventions

AG (experimental Andiroba Gel)

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the AG 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

KF2G (Potassium nitrate gel)

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2G received application of the potassium nitrate 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

PG (Placebo Gel)

Prior to bleaching treatment with 35% hydrogen peroxide, the PG group 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: No

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

Principal Investigators

Cecy M Silva, doctor

Role: PRINCIPAL_INVESTIGATOR

Universidade federal do Pará

Locations

UFPA

Belém, Pará, Brazil

Countries

Brazil

Other Identifiers

81021724.2.0000.0018

Identifier Type: -

Identifier Source: org_study_id