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

Primary Purpose

Child, Saliva, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Effect of aqueous propolis gums in salivary and dental plaque pH in children
Effect of placebo gums in salivary and dental plaque pH in children
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child focused on measuring Aqueous Propolis, Chewing gum

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aqueous propolis 5% gum

Placebo gum

Arm Description

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

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

Outcomes

Primary Outcome Measures

Saliva pH measurement
saliva pH will be measured by using saliva pH meter.
Saliva pH measurement
saliva pH will be measured by using saliva pH meter.
Saliva pH measurement
saliva pH will be measured by using saliva pH meter.

Secondary Outcome Measures

Dental plaque pH measurement
Dental plaque will be Orion SA 720 pH/ISE Meter

Full Information

First Posted
March 20, 2023
Last Updated
September 27, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05793099
Brief Title
Effect of 5% Aqueous Propolis in Salivary and Dental Plaque pH in Children
Official Title
Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
May 28, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Saliva, Dental Plaque
Keywords
Aqueous Propolis, Chewing gum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aqueous propolis 5% gum
Arm Type
Experimental
Arm Description
The children will be given aqueous propolis gums to chew for 15 minutes.
Arm Title
Placebo gum
Arm Type
Placebo Comparator
Arm Description
The children will be given placebo gums gums to chew for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Effect of aqueous propolis gums in salivary and dental plaque pH in children
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Effect of placebo gums in salivary and dental plaque pH in children
Intervention Description
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.
Primary Outcome Measure Information:
Title
Saliva pH measurement
Description
saliva pH will be measured by using saliva pH meter.
Time Frame
5 minutes after chewing gum.
Title
Saliva pH measurement
Description
saliva pH will be measured by using saliva pH meter.
Time Frame
10 minutes after chewing gum.
Title
Saliva pH measurement
Description
saliva pH will be measured by using saliva pH meter.
Time Frame
15 minutes after chewing gum.
Secondary Outcome Measure Information:
Title
Dental plaque pH measurement
Description
Dental plaque will be Orion SA 720 pH/ISE Meter
Time Frame
15 minutes after chewing gum.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman J Alahmad, DDs
Organizational Affiliation
MSc student in Pedodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shadi Azzawi, Phd
Organizational Affiliation
Professor of Pedodontics, Department of Pedodontics, University of Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24262397
Citation
Kumar S, Sogi SH, Indushekar KR. Comparative evaluation of the effects of xylitol and sugar-free chewing gums on salivary and dental plaque pH in children. J Indian Soc Pedod Prev Dent. 2013 Oct-Dec;31(4):240-4. doi: 10.4103/0970-4388.121822.
Results Reference
background
PubMed Identifier
32120052
Citation
Gargouri W, Kammoun R, Elleuche M, Tlili M, Kechaou N, Ghoul-Mazgar S. Effect of xylitol chewing gum enriched with propolis on dentin remineralization in vitro. Arch Oral Biol. 2020 Apr;112:104684. doi: 10.1016/j.archoralbio.2020.104684. Epub 2020 Feb 19.
Results Reference
background
PubMed Identifier
1305985
Citation
Toors FA. [Chewing gum and dental health. Literature review]. Rev Belge Med Dent (1984). 1992;47(3):67-92. French.
Results Reference
background
PubMed Identifier
35490523
Citation
Monteil J, Hadj-Sassi A, Dargelos E, Guzman-Barrera N, Poque E, Leal-Calderon F. Method to prepare aqueous propolis dispersions based on phase separation. Food Chem. 2022 Sep 30;389:133072. doi: 10.1016/j.foodchem.2022.133072. Epub 2022 Apr 25.
Results Reference
background
PubMed Identifier
30607063
Citation
Abbasi AJ, Mohammadi F, Bayat M, Gema SM, Ghadirian H, Seifi H, Bayat H, Bahrami N. Applications of Propolis in Dentistry: A Review. Ethiop J Health Sci. 2018 Jul;28(4):505-512. doi: 10.4314/ejhs.v28i4.16.
Results Reference
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Effect of 5% Aqueous Propolis in Salivary and Dental Plaque pH in Children

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