Effect of Andiroba on Control of Post-whitening Tooth Sensitivity

NCT06614764 | Completed

• 1 other identifier: 81021724.2.0000.0018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Tooth Bleaching; Pain; Dentin Desensitizing Agents

Outcome Measures

Primary Outcomes (1)

• Post-whitening sensitivity assessment

  To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 21 days of treatment, based on their individual perception of pain. This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session. The assessment form will consist of a 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 will be 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 can later be measured with the aid of a millimeter ruler, thus obtaining the patient\'s pain intensity level.

  Period: 21 days

Secondary Outcomes (1)

• Color evaluation

  Baseline (Ti) and one week after the 3rd whitening session (Tf).

Study Arms (3)

PG- Placebo gel

PLACEBO COMPARATOR

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

Other: PG (Placebo Gel)

GKF2- Potassium nitrate

ACTIVE COMPARATOR

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

Other: KF2G (Potassium nitrate gel)

AG- Andiroba Gel

EXPERIMENTAL

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

Other: AG (experimental Andiroba Gel)

Interventions

AG (experimental Andiroba Gel) 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.

AG- Andiroba Gel

KF2G (Potassium nitrate gel) 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.

GKF2- Potassium nitrate

PG (Placebo Gel) 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.

PG- Placebo gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

UFPA

Belém, Pará, 66075-110, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cecy M Silva, doctor

  Universidade federal do Pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Graduate Program in Dentistry at the Federal University of Pará

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)