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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05793099
• Other study ID #: UDDS-Pedo-05-2023
• Status: Completed
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 28, 2023
• Est. primary completion date: May 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Dental Plaque
• Saliva

Intervention

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.
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saliva pH measurement	saliva pH will be measured by using saliva pH meter.	5 minutes after chewing gum.
Primary	Saliva pH measurement	saliva pH will be measured by using saliva pH meter.	10 minutes after chewing gum.
Primary	Saliva pH measurement	saliva pH will be measured by using saliva pH meter.	15 minutes after chewing gum.
Secondary	Dental plaque pH measurement	Dental plaque will be Orion SA 720 pH/ISE Meter	15 minutes after chewing gum.