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

Not Applicable

Completed

• Conditions: Saliva; Dental Plaque; Child
• Interventions: Other: Effect of placebo gums in salivary and dental plaque pH in children; Other: Effect of aqueous propolis gums in salivary and dental plaque pH in children

• Registration Number: NCT05793099
• Lead Sponsor: Damascus University

Brief Summary

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.

Detailed 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).)

Study Timeline

• Study Start: 2022-12-16
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Primary Completion: 2023-05-28
• Study Completion: 2023-07-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo gum	Effect of placebo gums in salivary and dental plaque pH in children	The children will be given placebo gums gums to chew for 15 minutes.
Aqueous propolis 5% gum	Effect of aqueous propolis gums in salivary and dental plaque pH in children	The children will be given aqueous propolis gums to chew for 15 minutes.

Primary Outcome Measures

Name	Time	Method
Saliva pH measurement	15 minutes after chewing gum.	saliva pH will be measured by using saliva pH meter.

Secondary Outcome Measures

Name	Time	Method
Dental plaque pH measurement	15 minutes after chewing gum.	Dental plaque will be Orion SA 720 pH/ISE Meter

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic