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NOT YET RECRUITING
NCT07875387
NA

Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial

Sponsor: Pharos University in Alexandria

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-11-01

Completion Date

2027-02-01

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

OTHER

Bioactive glass topical varnish

topical preventive measure to resist dental caries

OTHER

Fluoride varnish

traditional preventive measure to dental caries