Dental PlaquePhase 2/3NCT03394729
Effect of a Propolis Tablet on the Saliva and the Amount of Adolescent Dental Plaque Microbes
A Phase 2/3 study testing Propolis tablet to limit dental biofilm and Xilytol tablet to limit dental biofilm in people with Dental Plaque, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Propolis tablet to limit dental biofilm and Xilytol tablet to limit dental biofilm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Sep 2017to 21 Oct 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals aged 10-19 years;
- Both genders;
- Individuals without cavitary caries lesions;
- Healthy individuals without any systemic diseases.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22245120
About this study
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
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.
Read the 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.
- Conditions
- Dental Plaque
- Being tested
- Propolis tablet to limit dental biofilm, Xilytol tablet to limit dental biofilm
- Keywords
- Propole, Xylitol, Saliva
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis tablet to limit dental biofilmDrug
Also called Propolis+Xylitol 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
Xilytol tablet to limit dental biofilmDrug
Also called Xylitol 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.
| Study group | Role | What they receive |
|---|---|---|
| Propolis tablet to limit dental biofilm | Experimental | 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. Receives: Drug: Propolis tablet to limit dental biofilm |
| Xilytol tablet to limit dental biofilm | Active comparator | 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. Receives: Drug: Xilytol tablet to limit dental biofilm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
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
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start29 Sep 2017
- Primary completion21 Oct 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical trial of prevention, cross, blind, randomized controlled with two arms in the study phase 2-3.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Mariana Leonel Martins, Universidade Federal do Rio de Janeiro
- Investigators
- Andréa F Gonçalves, Doctorate, Study director, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394729
- Sponsor's protocol ID
- TabletUFRJPed
- Status last verified
- Nov 2020
- First submitted
- 26 Dec 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25728105
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03394729
- Acronym / sponsor ID
- TabletUFRJPed
- Conditions
- Dental Plaque
- Keywords
- Propole, Xylitol, Saliva
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical trial of prevention, cross, blind, randomized controlled with two arms in the study phase 2-3.
| Arm | Type | Receives |
|---|---|---|
| Propolis tablet to limit dental biofilm | Experimental | Drug: Propolis tablet to limit dental biofilmIndividuals 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. |
| Xilytol tablet to limit dental biofilm | Active comparator | Drug: Xilytol tablet to limit dental biofilmIndividuals 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Individuals aged 10-19 years;
- Both genders;
- Individuals without cavitary caries lesions;
- Healthy individuals without any systemic diseases.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolis tablet to limit dental biofilmAlso: Propolis+Xylitol tabletThe 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 | Drug | Propolis tablet to limit dental biofilm |
| Xilytol tablet to limit dental biofilmAlso: Xylitol tabletThe 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. | Drug | Xilytol tablet to limit dental biofilm |
Primary outcome
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.
2 secondary outcomes
Concentration of soluble and insoluble extracellular polysaccharides of the biofilm of adolescents
Time frame: 7 days
Acceptability of tablets
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 25728105Tulsani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andréa F Gonçalves, Doctorate study director
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Propolis tablet to limit dental biofilm and Xilytol tablet to limit dental biofilm in people with Dental Plaque, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total microorganism count of adolescents biofilm (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.