- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03812315
Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children
Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children: A Randomized Clinical Trial
Propolis is a natural product collected by bees to seal holes and repair structures in their hives. Recently it has attracted much attention as useful substance applied in medicine and cosmetics thanks to its antimicrobial properties. Contemporary dentistry is an inseparable part of medicine and therefore attempts were made to use propolis in dentistry, as well.
Purpose of the study: to investigate the effect of propolis administered in chewing gum as compared to that incorporated in mouthwash on plaque accumulation, microbial population and patient acceptance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alexandria, Egypt, 21512
- Faculty of Dentistry, Alexandria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with high caries risk; who have any one of the following condition: visible cavities or radiographic penetration into the dentin, white spots on smooth surfaces, restorations within last three years due to caries.
- Free of any systemic condition.
- Cooperative children according to Frankl rating scale including positive and definitely positive scores.
- Parental acceptance
Exclusion Criteria:
- Previous use of any propolis containing products.
- Received any antibiotic 2 weeks before or during the study.
- Oral infection that compromises the mastication process.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Propolis chewing gum
2 % pure raw propolis, 20-35% gum base, 2.5% flavors, 0.3% sorbitol and 0.3% coloring substance.
Children will be instructed to chew the specially prepared propolis chewing gum for at least 20 minutes, twice daily, after breakfast and before bedtime.
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Children who will use chewing gum will be instructed to chew a gum for 20 minutes once after breakfast and another before bed time for two weeks.
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ACTIVE_COMPARATOR: Propolis mouthwash
The formulation includes 2% pure raw propolis, 40 ml flavors, 150 ml propylene glycol, 60 gm sorbitol, 0.1 g coloring substance and water.
Children will be instructed to rinse using the prepared propolis mouthwash for 1 min, twice a day, after breakfast and before bedtime.
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Children who will use mouthwash will be instructed to rinse with 10 ml for 60 seconds twice daily once after breakfast and another before bedtime for two weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plaque Accumulation
Time Frame: Baseline and after 2 weeks
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All children will be examined clinically using the Plaque Control record (O' Leary, Darke and Naylor). The child will be asked to chew a disclosing tablet and let it mix with saliva for 30 seconds and spit it out. Each tooth is divided into 4 surfaces; the plaque accumulations on all surfaces will be scored. The number of positively scored units is divided by the total number of tooth surfaces evaluated, and the result is multiplied by 100 to express the index as a percentage. |
Baseline and after 2 weeks
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Microbiological Sampling of Dental Plaque
Time Frame: Baseline and after 2 weeks
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On the day of sampling, each child will refrain from tooth brushing in the morning, eating or drinking (except water) at least two hours before sampling time.
The plaque will be collected using sterilized toothpicks.
Two plaque samples will be collected from each child.
Anteriorly, this will be gathered from the buccal and palatal surface of the upper incisors and canines.
While posteriorly, the plaque sample will be collected from the upper and lower molars.
Finally, each plaque sample will be inoculated in separate vials; each vial contains 1 ml sterile brain heart infusion broth and will be sent to the lab.
After 14 days, another plaque sample will be collected as previously mentioned.
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Baseline and after 2 weeks
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Assessment of Patient's Acceptance
Time Frame: After 2 weeks of treatment
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Using Visual Analogue Scale (VAS).Each patient will receive the scale form and instructed to place a vertical mark according his or her personal rating of the preparation received during the treatment period on a horizontal line scaled from 0 to 10 where 0 presented for unacceptable and 10 for acceptable.
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After 2 weeks of treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hend S El-Allaky, Alexandria University
- Study Director: Nadia A Wahba, Alexandria University
- Study Director: Dalia AM Talaat, Alexandria University
- Study Director: Azza S Zakaria, Faculty of Pharmacy, Alexandria University
Publications and helpful links
General Publications
- Imfeld T. Chewing gum--facts and fiction: a review of gum-chewing and oral health. Crit Rev Oral Biol Med. 1999;10(3):405-19. doi: 10.1177/10454411990100030901.
- Balouiri M, Sadiki M, Ibnsouda SK. Methods for in vitro evaluating antimicrobial activity: A review. J Pharm Anal. 2016 Apr;6(2):71-79. doi: 10.1016/j.jpha.2015.11.005. Epub 2015 Dec 2.
- Santos FA, Bastos EM, Maia AB, Uzeda M, Carvalho MA, Farias LM, Moreira ES. Brazilian propolis: physicochemical properties, plant origin and antibacterial activity on periodontopathogens. Phytother Res. 2003 Mar;17(3):285-9. doi: 10.1002/ptr.1117.
- Dodwad V, Kukreja BJ. Propolis mouthwash: A new beginning. J Indian Soc Periodontol. 2011 Apr;15(2):121-5. doi: 10.4103/0972-124X.84379.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Propolis in 2 vehicles
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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