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

Nourhan M.Aly

Status and phase: Completed; Phase 2

Conditions: Early Childhood Caries

Treatments: Combination Product: Propolis chewing gum; Combination Product: Propolis mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT03812315

Propolis in 2 vehicles

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No 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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Propolis chewing gum

Experimental group

Description:

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.

Treatment:

Combination Product: Propolis chewing gum

Propolis mouthwash

Active Comparator group

Description:

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.

Treatment:

Combination Product: Propolis mouthwash