Caries Clinical Trial
Official title:
The Antimicrobial Activity and Clinical Performance of Chitosan-modified Glass Ionomer: A Randomized Clinical Trial
Verified date | January 2021 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as control when used in primary molars
Status | Completed |
Enrollment | 65 |
Est. completion date | January 5, 2021 |
Est. primary completion date | January 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 8 Years |
Eligibility | Inclusion Criteria: The teeth will be primary molars selected from patients presented to the outpatient clinic that are - Healthy patients. - Age: 4-8 years. - Children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (Ø=0.9 mm). Exclusion Criteria: - Teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis. - Children with systemic diseases. - Patients with history of active para-functional oral habits, xerostomia. - Patients who will have difficulties in cooperating. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Ibrahim MA, Meera Priyadarshini B, Neo J, Fawzy AS. Characterization of Chitosan/TiO(2) Nano-Powder Modified Glass-Ionomer Cement for Restorative Dental Applications. J Esthet Restor Dent. 2017 Apr;29(2):146-156. doi: 10.1111/jerd.12282. Epub 2017 Feb 12. — View Citation
Ibrahim MA, Neo J, Esguerra RJ, Fawzy AS. Characterization of antibacterial and adhesion properties of chitosan-modified glass ionomer cement. J Biomater Appl. 2015 Oct;30(4):409-19. doi: 10.1177/0885328215589672. Epub 2015 Jun 15. — View Citation
Kabil NS, Badran AS, Wassel MO. Effect of the addition of chlorhexidine and miswak extract on the clinical performance and antibacterial properties of conventional glass ionomer: an in vivo study. Int J Paediatr Dent. 2017 Sep;27(5):380-387. doi: 10.1111/ — View Citation
Mulder R, Anderson-Small C. Ion release of chitosan and nanodiamond modified glass ionomer restorative cements. Clin Cosmet Investig Dent. 2019 Sep 6;11:313-320. doi: 10.2147/CCIDE.S220089. eCollection 2019. — View Citation
Wassel MO, Khattab MA. Antibacterial activity against Streptococcus mutans and inhibition of bacterial induced enamel demineralization of propolis, miswak, and chitosan nanoparticles based dental varnishes. J Adv Res. 2017 Jul;8(4):387-392. doi: 10.1016/j.jare.2017.05.006. Epub 2017 May 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibacterial | Dentin samples incubated on 2 culture mediums and total bacterial count by counting colony forming units will be counted. Higher number means Less antibacterial effect | 9 months | |
Primary | Clinical performance | "Modified United States Public Health Service Ryge Criteria" for Direct Clinical Evaluation and rating of Restoration.measuring color match, anatomic contour, marginal integrity, cavosurface marginal discoloration, secondary caries, surface texture, gross fracture.
each outcome will be graded Alpha(A) for the highest score, Bravo(b) for moderate score, and Charlie(C) for the lowest score. |
followup 9 months |
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