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)
Verified date | September 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Damascus University | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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
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. |
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