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NCT07875387
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Conditions: Prevention of Dental Caries
Sex: All
Ages: 6 Months – 12 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Pharos University in Alexandria
Summary
This study is a two-arm parallel randomized controlled trial led by Principal Investigator Inas Karawia at the Faculty of Dentistry, designed to evaluate and compare the short-term (immediatly) and sustained (over 6 months) effects of a single application of bioactive glass varnish versus traditional fluoride varnish on salivary parameters in healthy children aged 6-12 years with normal salivary flow and no active caries. Unstimulated morning saliva samples (collected between 9:00-11:00 AM) will be assessed at baseline, 1 week, and 1 month to evaluate changes in salivary pH (via a calibrated digital pH meter), flow rate (in mL/min over 5 minutes), and Streptococcus mutans bacterial counts (in CFU/mL via culturing on Mitis Salivarius Bacitracin agar). With sample size determined using G\*Power software to ensure 80% statistical power \& alpha = 0.05), the collected longitudinal data across both groups will be analyzed using Two-Way Repeated Measures ANOVA and student t test between the 2 groups in SPSS to detect significant differences over time and between treatments.
Eligibility Criteria
Inclusion Criteria:
* Healthy children with no active dental caries or oral lesions
* Normal salivary flow rate
* Willingness to participate
Exclusion Criteria:
* • History of systemic illness or medication affecting salivary secretion
* Recent use (within 1 month) of antibiotics, mouthwash, or fluoride varnish
Source: ClinicalTrials.gov (NCT07875387). StuddyBuddy aggregates publicly available trial information.