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

• Sponsor: Damascus University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05793099
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.4
• Patients Per Site Per Month: 4.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Child; Saliva; Dental Plaque	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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of 5% Aqueous Propolis Added to Sugar-Free Chewing Gum in Salivary and Dental Plaque pH in Children (in Vivo Study)
• Actual Study Start Date: Dec 16, 2022
• Anticipated Primary Completion Date: May 28, 2023
• Anticipated Study Completion Date: Jul 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aqueous propolis 5% gum 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; 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.
Placebo Comparator: Placebo gum 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; 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.

Outcome Measures

Primary Outcome Measures

1. Saliva pH measurement [5 minutes after chewing gum.]

   saliva pH will be measured by using saliva pH meter.

2. Saliva pH measurement [10 minutes after chewing gum.]

   saliva pH will be measured by using saliva pH meter.

3. Saliva pH measurement [15 minutes after chewing gum.]

   saliva pH will be measured by using saliva pH meter.

Secondary Outcome Measures

1. Dental plaque pH measurement [15 minutes after chewing gum.]

   Dental plaque will be Orion SA 720 pH/ISE Meter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damascus University	Damascus		Syrian Arab Republic

Sponsors and Collaborators

• Damascus University

Investigators

• Principal Investigator: Iman J Alahmad, DDs, MSc student in Pedodontics, University of Damascus
• Study Director: Shadi Azzawi, Phd, Professor of Pedodontics, Department of Pedodontics, University of Damascus

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• Toors FA. [Chewing gum and dental health. Literature review]. Rev Belge Med Dent (1984). 1992;47(3):67-92. French.

• Responsible Party: Damascus University
• ClinicalTrials.gov Identifier: NCT05793099
• Other Study ID Numbers: UDDS-Pedo-05-2023
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Damascus University: Aqueous Propolis; Chewing gum
• Additional relevant MeSH terms: Dental Plaque; Propolis

Study Results

No Results Posted as of Mar 31, 2023