Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children

Sponsor

Nourhan M.Aly (Other)

Overall Status

Completed

CT.gov ID

NCT03812315

Collaborator

Alexandria University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early Childhood Caries	Combination Product: Propolis chewing gum Combination Product: Propolis mouthwash	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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)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)

Masking:

Single (Outcomes Assessor)

Masking Description:

The investigator and the participants will not be blinded to the treatment type as each group has to be given different instruction according to their treatment protocol. However, the statistician and the microbiologist will be blinded to the treatment group.

Primary Purpose:

Prevention

Official Title:

Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children: A Randomized Clinical Trial

Actual Study Start Date :

Dec 20, 2017

Actual Primary Completion Date :

Feb 10, 2019

Actual Study Completion Date :

Feb 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Combination Product: Propolis chewing gum 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.
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.	Combination Product: Propolis mouthwash 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.

Arm

Intervention/Treatment

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.

Combination Product: Propolis chewing gum

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.

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.

Combination Product: Propolis mouthwash

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.

Outcome Measures

Primary Outcome Measures

Change in Plaque Accumulation [Baseline and after 2 weeks]
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.
Microbiological Sampling of Dental Plaque [Baseline and after 2 weeks]
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.
Assessment of Patient's Acceptance [After 2 weeks of treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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