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

Official title

Effects of a 0.5% Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial

Overview

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%.

Detailed description

All groups will undergo in-office whitening treatment, carried out in 2 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 30 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.

Interventions

• Other Placebo - gel KY original
  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.
• Other Propolis gel
  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.
• Other KF2- Potassium nitrate
  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.

Primary outcome measures

• Post-whitening sensitivity assessment [Time frame: 14 days]

Secondary outcome measures (1)

• Color evaluation [Time frame: Baseline (T0) and one week after the 2rd whitening session (T1)]

Eligibility criteria

Inclusion criteria

• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• UFPA — Belém

Identifiers

NCT: NCT07569276 · 93881125.4.0000.0018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗