Effect of 5% Aqueous Propolis in Salivary and Dental Plaque pH in Children

Damascus University

Status: Completed

Conditions: Saliva; Dental Plaque; Child

Treatments: Other: Effect of aqueous propolis gums in salivary and dental plaque pH in children; Other: Effect of placebo gums in salivary and dental plaque pH in children

Study type: Interventional

Funder types: Other

Identifiers

NCT05793099

UDDS-Pedo-05-2023

Details and patient eligibility

About

This study aims to investigate the changes in saliva and dental plaque pH after consuming sugar-free chewing gum containing 5% of aqueous propolis in children aged between 8-11 years. The studied sample will be divided into two groups: Group A (Control group) placebo chewing gum, and Group B (Experimental group) aqueous propolis chewing gum. All children will experience both types of chewing gum with an interval of 1 week between the two studied groups.

Full description

This study will evaluate saliva and dental plaque pH after consuming 10% sucrose solution and then each child will test each of the two types of gum (aqueous propolis 5% and placebo gum) so that the child himself is the control and tested sample together, according to the following order:

• In the first visit: the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing one of the two types of gum, and after giving the sucrose solution).
• In the second visit: after a week, the pH of saliva and dental plaque will be measured (before giving the sucrose solution, while chewing the other types of gum, and after giving the sucrose solution).)

Enrollment: 30 patients

Sex: All

Ages: 8 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children have mixed occlusion.
2. Integrity of the buccal surfaces of the reference teeth (16, 21, 26, 36, 41, 46) from caries and developmental disorders
3. Children with DMFS ≥5 according to WHO guidelines and standards.

Exclusion criteria

1. Systematic or mental disorders
2. Medications that may affect the salivary flow rate or composition.
3. Allergy to natural sugar substitutes.
4. Children who wear fixed or removable orthodontic appliances.
5. Children who have the habit of daily use of sugar substitute products.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Aqueous propolis 5% gum

Experimental group

Description:

The children will be given aqueous propolis gums to chew for 15 minutes.

Treatment:

Other: Effect of aqueous propolis gums in salivary and dental plaque pH in children

Placebo gum

Placebo Comparator group

Description:

The children will be given placebo gums gums to chew for 15 minutes.

Treatment:

Other: Effect of placebo gums in salivary and dental plaque pH in children