Clinical trial NCT03812315: Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children
Official title: Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Early Childhood Caries
Keywords: Propoplis
chewing gum
mouthwash
high caries risk children
antimicrobial
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Plaque Accumulation
timeFrame: Baseline and after 2 weeks
measure: Microbiological Sampling of Dental Plaque
timeFrame: Baseline and after 2 weeks
measure: Assessment of Patient's Acceptance
timeFrame: After 2 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Hend S El-Allaky
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Nadia A Wahba
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Dalia AM Talaat
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Alexandria University
name: Azza S Zakaria
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.