Propolis in Reducing Dentin Hypersensitivity

NCT05083052 | Completed DMC

• 1 other identifier: UFPa - 0011
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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%.

Conditions

Dentin Sensitivity

Keywords

Dentin Desensitizing Agents; Propolis.

Outcome Measures

Primary Outcomes (1)

• Dentin hypersensitivity

  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.

  30 days

Secondary Outcomes (1)

• Quality of life

  30 days

Study Arms (3)

PLACEBO

PLACEBO COMPARATOR

Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Água deionizada q.s.p - 100mL.

Other: Placebo

PROPOLIS 10%

EXPERIMENTAL

Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Própolis a 10%, Água deionizada q.s.p - 100mL.

Other: Propolis 10%

PROPOLIS 15%

EXPERIMENTAL

Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Própolis a 15%, Água deionizada q.s.p - 100mL.

Other: Propolis 15%

Interventions

Propolis 15% OTHER

oothpaste formulation with 15% propolis.

PROPOLIS 15%

Propolis 10% OTHER

Toothpaste formulation with 10% propolis.

PROPOLIS 10%

Placebo OTHER

Formulation of toothpaste without active ingredient.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Universidade Federal do Pará

Belém, Pará, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Cecy M Silva, PhD

  Federal University of Pará

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: November 5, 2020
• Primary Completion: November 5, 2021
• Study Completion: December 20, 2021
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)