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

Study Overview
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Brief Summary
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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
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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).)

Official Title
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Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)

Conditions
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Child, Saliva, Dental Plaque

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children have mixed occlusion. Integrity of the buccal surfaces of the reference teeth (16, 21, 26, 36, 41, 46) from caries and developmental disorders Children with DMFS ≥5 according to WHO guidelines and standards. Exclusion Criteria: Systematic or mental disorders Medications that may affect the salivary flow rate or composition. Allergy to natural sugar substitutes. Children who wear fixed or removable orthodontic appliances. Children who have the habit of daily use of sugar substitute products.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aqueous propolis 5% gum<br>The children will be given aqueous propolis gums to chew for 15 minutes. | Other: Effect of aqueous propolis gums in salivary and dental plaque pH in children<br>* The child will be given a 10% sucrose solution, and the salivary pH will be measured before and after giving sucrose solution (Baseline) and then the child will be given aqueous propolis gum to chew for 15 minutes to stimulate salivation. The saliva pH will be measured by taking a sample of the patient's saliva (3ml) while chewing the gum in the mouth in a disposable container and then saliva pH will be measured. Dental plaque pH also will be measured before and after administration of a 10% sucrose solution (Baseline), and then 15 minutes after chewing aqueous propolis gum dental plaque will be collected using the plaque collection technique from the 6 buccal surfaces of teeth 16,21,26,36,41,46 using a sterile excavator. The sample will be mixed with 0.05 ml of distilled water until it dissolves and then dental plaque pH will be measured.<br>|
| Placebo Comparator: Placebo gum<br>The children will be given placebo gums gums to chew for 15 minutes. | Other: Effect of placebo gums in salivary and dental plaque pH in children<br>* The child will be given a 10% sucrose solution, and the salivary pH will be measured before and after giving sucrose solution (Baseline) and then the child will be given placebo gum to chew for 15 minutes to stimulate salivation. The saliva pH will be measured by taking a sample of the patient's saliva (3ml) while chewing the gum in the mouth in a disposable container and then saliva pH will be measured. Dental plaque pH also will be measured before and after administration of a 10% sucrose solution (Baseline), and then 15 minutes after chewing placebo gum dental plaque will be collected using the plaque collection technique from the 6 buccal surfaces of teeth 16,21,26,36,41,46 using a sterile excavator. The sample will be mixed with 0.05 ml of distilled water until it dissolves and then dental plaque pH will be measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva pH measurement | saliva pH will be measured by using saliva pH meter. | 5 minutes after chewing gum. | 
| Saliva pH measurement | saliva pH will be measured by using saliva pH meter. | 10 minutes after chewing gum. | 
| Saliva pH measurement | saliva pH will be measured by using saliva pH meter. | 15 minutes after chewing gum. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental plaque pH measurement | Dental plaque will be Orion SA 720 pH/ISE Meter | 15 minutes after chewing gum. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aqueous Propolis, Chewing gum