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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2019-02-20

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Propolis chewing gum

Intervention Type COMBINATION_PRODUCT

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.

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.

Group Type ACTIVE_COMPARATOR

Propolis mouthwash

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No