Clinical trial NCT05083052: Propolis in Reducing Dentin Hypersensitivity
Official title: Propolis in Reducing Dentin Hypersensitivity: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Dentin Desensitizing Agents; Propolis.
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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%.


Eligibility criteria: 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.

Primary outcomes:
measure: Dentin hypersensitivity
timeFrame: 30 days
Secondary outcomes:
measure: Quality of life
timeFrame: 30 days
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade Federal do Pará
state: PA
Study officials:
affiliation: Federal University of Pará
name: Cecy M Silva, PhD
role: STUDY_CHAIR
References: