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

Sponsor
Universidade Federal do Para
Study ID
NCT07569276
Status
Not Yet Recruiting

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Conditions

  • Dentin Desensitizing Agents
  • Pain
  • Tooth Bleaching

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.

Study Details

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%.

Key Dates

First listed
May 6, 2026
Start date
Apr 29, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo- KY original gel
    The Placebo group received the application of placebo gel for post tooth bleaching sensitivity.
  • Active Comparator: KF2- Potassium nitrate
    The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.
  • Experimental: Propolis- Propolis 0,5% gel
    The Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity.

Primary Outcome Measure

Post-whitening sensitivity assessment [ Time Frame: 14 days ]

Central Contacts

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