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Propolis in Reducing Dentin Hypersensitivity

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Propolis 15%
Propolis 10%
Placebo
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Dentin Desensitizing Agents; Propolis.

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal do Pará

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

PLACEBO

PROPOLIS 10%

PROPOLIS 15%

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life
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.

Full Information

First Posted
October 6, 2021
Last Updated
May 17, 2022
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT05083052
Brief Title
Propolis in Reducing Dentin Hypersensitivity
Official Title
Propolis in Reducing Dentin Hypersensitivity: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Dentin Desensitizing Agents; Propolis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
PROPOLIS 10%
Arm Type
Experimental
Arm Description
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.
Arm Title
PROPOLIS 15%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Propolis 15%
Intervention Description
oothpaste formulation with 15% propolis.
Intervention Type
Other
Intervention Name(s)
Propolis 10%
Intervention Description
Toothpaste formulation with 10% propolis.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Formulation of toothpaste without active ingredient.
Primary Outcome Measure Information:
Title
Dentin hypersensitivity
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecy M Silva, PhD
Organizational Affiliation
Federal University of Pará
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal do Pará
City
Belém
State/Province
PA
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Propolis in Reducing Dentin Hypersensitivity

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