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Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Propolis tablet to limit dental biofilm
Xilytol tablet to limit dental biofilm
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Propole, Xylitol, Saliva

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals aged 10-19 years;
  • Both genders;
  • Individuals without cavitary caries lesions;
  • Healthy individuals without any systemic diseases.

Exclusion Criteria:

  • Individuals intolerant to some component of the propolis-containing tablet;
  • Subjects undergoing antimicrobial treatment during the course of the study or for a period of 30 days prior to the study;
  • Individuals who used products containing xylitol up to 30 days before the start of study or during the course of the study;
  • Individuals who used products containing propolis up to 30 days before the start of the study or during the course of the study;
  • Individuals with orthodontic appliances;
  • Individuals who are using oral mouthwashes during the period of study;
  • Individuals with a history of intraoral surgery within the last 6 months;
  • Individuals who are making use of products rich in polyphenols: coffee, mate, acai, in the previous period (30 days) and during the research;
  • Individuals who consume alcohol.

Sites / Locations

  • Universidade Federal do Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propolis tablet to limit dental biofilm

Xilytol tablet to limit dental biofilm

Arm Description

Individuals will be instructed to consume the tablet with propolis and xilytol to control dental biofilm, twice a day (at 10am and 5pm) for 7 days, giving a 30 day interval between the test and the control tablet.

Individuals will be instructed to consume the tablet with xilytol to control dental biofilm, twice a day (at 10am and 5pm) for 7 days, giving a 30 day interval between the test and the control tablet.

Outcomes

Primary Outcome Measures

Total microorganism count of adolescents biofilm
Effect of xylitol tablets with and without propolis on the total microorganism count of adolescents biofilm using the scattering technique, considering the number of CFU/mg of biofilm.

Secondary Outcome Measures

Concentration of soluble and insoluble extracellular polysaccharides of the biofilm of adolescents
Effect of xylitol tablets with and without propolis on the concentration of soluble and insoluble extracellular polysaccharides of the biofilm of adolescents by means of the phenol-sulfuric method, based on the quantitative carbohydrate
Acceptability of tablets
The acceptability of tablets for the appearance, flavor, aroma and texture of the tablets, by adolescents, by means of a questionnaire with a scale of sensory acceptability with 9 points for each of the criteria: 9 - I liked it extremely (loved it); 8 - I liked it very much; 7 - I liked moderately; 6 - I liked it slightly; 5 - Neither liked nor disliked; 4 - I disagree slightly; 3 - I disliked moderately; 2 - I was very displeased; 1 - I greatly disliked (I hated it). The final value of this scale corresponds to the average of the scale criteria and the higher the score, the greater the sensory acceptability of the product.

Full Information

First Posted
December 26, 2017
Last Updated
November 3, 2020
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT03394729
Brief Title
Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes
Official Title
Effect of a Propolis-containing Tablet on the Acidity of Saliva and the Amount of Adolescent Dental Plaque Microbes: a Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
October 21, 2020 (Actual)
Study Completion Date
October 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

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
The aim of the present study was to evaluate the effect of a xylitol containing propolis tablet on the salivary pH, total microorganisms count and soluble and insoluble extracellular polysaccharide concentration of the dental biofilm of adolescents in a randomized controlled clinical trial. In addition, evaluate the acceptability of the individuals regarding the characteristics of the tablets (appearance, taste, aroma and texture) through a questionnaire. To that end, healthy adolescents between 10 and 19 years old, without active carious lesions, who seek care at the Pediatric Dentistry Clinic of the Universidade Federal do Rio de Janeiro (UFRJ) will be randomly assigned to the two groups of the study: control group (propolis- consumers of tablets with propolis), respecting an interval of 30 days of rest between the consumption of the tablets. The study will be cross-checked and the principal investigator will be blind. The tablets will be given to the participants on an exact number of days of use and they will be instructed to consume two tablets per day for 7 uninterrupted days. After 30 days of interval, they will consume the other type of tablet with the same recommendations of the first one. The total non-stimulated saliva collection will be performed at the beginning of the study (before the consumption of the tablets) and 7 days after the intervention of each type of tablet, as well as the collection of the dental biofilm. Saliva and biofilm samples from all individuals will be identified and later analyzed in the laboratory, on the same day of collection, to measure the salivary pH, with the aid of a phmeter, and evaluation of the growth of total microorganisms (CFU / mg biofilm ), respectively. From the biofilm collected and stored in saline, concentrations of soluble and insoluble extracellular polysaccharides will also be measured by means of a spectrophotometer. Statistical tests will be used to compare the groups, with a significance level of 5%. As results, the propolis-containing tablet is expected to increase the salivary pH and decrease the number of total microorganisms in the dental biofilm.
Detailed Description
Test tablets (with xylitol and propolis) and control (xylitol only) will be offered in an exact number of days of use to be consumed orally. Collection of total non-stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days, for both types of pellets and both tests. All individuals (n=300) will use the tablet with and without propolis, respecting interval of 30 days without consumption of any other tablet or substance containing propolis and/or xylitol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Propole, Xylitol, Saliva

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Clinical trial of prevention, cross, blind, randomized controlled with two arms in the study phase 2-3.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
In the study, the principal investigator will be blind to the order of the tablets consumed by adolescents. The propolis tablets and control tablets will have a similar appearance, taste, texture and sizes, will be coded as "A" and "B" by an independent investigator and will be delivered to participants in an opaque and closed bottle. Individuals will be instructed to consume each type of tablet (propolis and propolis) twice a day (10 a.m. and 5 p.m.) for 7 days, giving a 30 day interval between test and control. Volunteers will be followed at the beginning and end of each intervention.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propolis tablet to limit dental biofilm
Arm Type
Experimental
Arm Description
Individuals will be instructed to consume the tablet with propolis and xilytol to control dental biofilm, twice a day (at 10am and 5pm) for 7 days, giving a 30 day interval between the test and the control tablet.
Arm Title
Xilytol tablet to limit dental biofilm
Arm Type
Active Comparator
Arm Description
Individuals will be instructed to consume the tablet with xilytol to control dental biofilm, twice a day (at 10am and 5pm) for 7 days, giving a 30 day interval between the test and the control tablet.
Intervention Type
Drug
Intervention Name(s)
Propolis tablet to limit dental biofilm
Other Intervention Name(s)
Propolis+Xylitol tablet
Intervention Description
The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days
Intervention Type
Drug
Intervention Name(s)
Xilytol tablet to limit dental biofilm
Other Intervention Name(s)
Xylitol tablet
Intervention Description
The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days.
Primary Outcome Measure Information:
Title
Total microorganism count of adolescents biofilm
Description
Effect of xylitol tablets with and without propolis on the total microorganism count of adolescents biofilm using the scattering technique, considering the number of CFU/mg of biofilm.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Concentration of soluble and insoluble extracellular polysaccharides of the biofilm of adolescents
Description
Effect of xylitol tablets with and without propolis on the concentration of soluble and insoluble extracellular polysaccharides of the biofilm of adolescents by means of the phenol-sulfuric method, based on the quantitative carbohydrate
Time Frame
7 days
Title
Acceptability of tablets
Description
The acceptability of tablets for the appearance, flavor, aroma and texture of the tablets, by adolescents, by means of a questionnaire with a scale of sensory acceptability with 9 points for each of the criteria: 9 - I liked it extremely (loved it); 8 - I liked it very much; 7 - I liked moderately; 6 - I liked it slightly; 5 - Neither liked nor disliked; 4 - I disagree slightly; 3 - I disliked moderately; 2 - I was very displeased; 1 - I greatly disliked (I hated it). The final value of this scale corresponds to the average of the scale criteria and the higher the score, the greater the sensory acceptability of the product.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals aged 10-19 years; Both genders; Individuals without cavitary caries lesions; Healthy individuals without any systemic diseases. Exclusion Criteria: Individuals intolerant to some component of the propolis-containing tablet; Subjects undergoing antimicrobial treatment during the course of the study or for a period of 30 days prior to the study; Individuals who used products containing xylitol up to 30 days before the start of study or during the course of the study; Individuals who used products containing propolis up to 30 days before the start of the study or during the course of the study; Individuals with orthodontic appliances; Individuals who are using oral mouthwashes during the period of study; Individuals with a history of intraoral surgery within the last 6 months; Individuals who are making use of products rich in polyphenols: coffee, mate, acai, in the previous period (30 days) and during the research; Individuals who consume alcohol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andréa F Gonçalves, Doctorate
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22245120
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25728105
Citation
Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.
Results Reference
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Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes

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