Effects of an Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial

NCT07569276 | Not Yet Recruiting

• 1 other identifier: 93881125.4.0000.0018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching. Sixty-six volunteers will be selected according to inclusion and exclusion criteria and will be randomly assigned to three experimental groups: Placebo - received application of a gel without active ingredient (K-Y Original), KF2 - received application of 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and Propolis 0.5% - application of the experimental 0.5% propolis gel. All participants will undergo two in-office bleaching sessions with 35% hydrogen peroxide, with seven-day intervals between them. The bleaching agent will be applied for 30 minutes. The desensitizing agents will be applied prior to bleaching and kept in contact with the vestibular dental surface for ten minutes. Sensitivity will be monitored daily using the Visual Analogue Scale for fourteen days, while color change will be determined by spectrophotometry, using the parameters of the CIELab\* system and calculation of ΔE00, measured before bleaching (T0) and 7 days after the second bleaching session (T1). The data will be subjected to statistical analysis according to sample distribution, adopting a power of 80% and a significance level of 5%.

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 14 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.

  14 days

Secondary Outcomes (1)

• Color evaluation

  Baseline (T0) and one week after the 2rd whitening session (T1)

Study Arms (3)

Placebo- KY original gel

PLACEBO COMPARATOR

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

Other: Placebo - gel KY original

KF2- Potassium nitrate

ACTIVE COMPARATOR

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

Other: KF2- Potassium nitrate

Propolis- Propolis 0,5% gel

EXPERIMENTAL

The Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity.

Other: Propolis gel

Interventions

Propolis gel OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the Propolis received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.

Propolis- Propolis 0,5% gel

KF2- Potassium nitrate OTHER

Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2 received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.

KF2- Potassium nitrate

Placebo - gel KY original OTHER

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

Placebo- KY original 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 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

Central Study Contacts

Cecy M Silva, Doctor

CONTACT

+55 (91) 3201-7563; cecymsilva@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, 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: April 29, 2026
• First Posted: May 6, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)