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Completed

NCT Number: NCT05083052

Propolis in Reducing Dentin Hypersensitivity

Objective: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life.

Materials and methods: Volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: Group 1- placebo - toothpaste without active ingredient, Group 2- toothpaste with 10% propolis and Group 3. - toothpaste with 15% propolis. Number of teeth will be used as sample unit, totaling 22 teeth per group. Volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS). The self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. The data regarding HD in VAS, if present normal distribution, will be used Two-way analysis of variance (ANOVA) with Tukey's post hoc for comparison between treatments. However, if the data show anormal distribution, Friedman to compare the different times in the same group (intra group), and Kruskal Wallis to make the comparison between groups (inter group). To evaluate the QEHD ordinal data, Wilcoxon and Mann-Whitney tests will be used. Bioestat 5.3 (Belém, Pará, Brazil) will be used, considering an alpha level of 5%.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Pará

Belém, Pará, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Two to four hypersensitive teeth with a response ≥ 04 on the visual analogue scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain, during the application of tactile (explorer probe) and evaporative (jet air);
  • Dentinal exposure on the posterior teeth, due to the presence of a shallow non-carious lesion up to 02 mm in depth, according to the Smith & Knight index (measured with a millimeter probe), and / or class I gingival recession according to Miller classification.

Exclusion criteria

  • Restorations; tooth decay and/or periodontal pockets; dental pulpitis; enamel cracks or fractures on sensitive teeth;
  • Continuous treatment with anti-inflammatory drugs and/or analgesics or desensitizing treatment induced three months prior to research recruitment data;
  • Pregnancy or lactation;
  • Systemic diseases;
  • Fixed orthodontic appliances;
  • Occlusal instability.

Treatment and study plan

Propolis 15%

Other

oothpaste formulation with 15% propolis.

Propolis 10%

Other

Toothpaste formulation with 10% propolis.

Placebo

Other

Formulation of toothpaste without active ingredient.

Primary outcomes

  1. Dentin hypersensitivity

    Time frame: 30 days

    The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain.

Secondary outcomes

  1. Quality of life

    Time frame: 30 days

    The self-reported evaluation of the volunteers will be completed through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Para

Other

Registry information

Official study title

Propolis in Reducing Dentin Hypersensitivity: a Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2021
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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