- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394729
Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes
November 3, 2020 updated by: Mariana Leonel Martins, Universidade Federal do Rio de Janeiro
Effect of a Propolis-containing Tablet on the Acidity of Saliva and the Amount of Adolescent Dental Plaque Microbes: a Randomized Clinical Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RJ
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Rio de Janeiro, RJ, Brazil, 22245120
- Universidade Federal do Rio de Janeiro
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Propolis tablet to limit dental biofilm
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.
|
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
Other Names:
|
Active Comparator: Xilytol tablet to limit dental biofilm
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total microorganism count of adolescents biofilm
Time Frame: 7 days
|
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.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of soluble and insoluble extracellular polysaccharides of the biofilm of adolescents
Time Frame: 7 days
|
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
|
7 days
|
Acceptability of tablets
Time Frame: 7 days
|
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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Andréa F Gonçalves, Doctorate, Universidade Federal do Rio de Janeiro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2017
Primary Completion (Actual)
October 21, 2020
Study Completion (Actual)
October 21, 2020
Study Registration Dates
First Submitted
December 26, 2017
First Submitted That Met QC Criteria
January 3, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TabletUFRJPed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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