Early Childhood Caries Clinical Trial
Official title:
Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children: A Randomized Clinical Trial
Verified date | February 2019 |
Source | University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 20, 2019 |
Est. primary completion date | February 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 8 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Nourhan M.Aly | Faculty of Dentistry, Alexandria University |
Egypt,
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. Review. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Plaque Accumulation | 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 | |
Primary | Microbiological Sampling of Dental Plaque | 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. | Baseline and after 2 weeks | |
Primary | Assessment of Patient's Acceptance | 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. | After 2 weeks of treatment |
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