An interventional study of Bioactive glass topical varnish and Fluoride varnish in Prevention of Dental Caries, sponsored by Pharos University in Alexandria. Not yet recruiting. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Pharos University in Alexandria · Not applicable, Interventional, and Prevention
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.
Bioactive glass is a biomaterial of interest in preventive dentistry because of its interaction with the oral environment and its potential to release mineral ions. Fluoride varnish is an established preventive dental material, while bioactive glass varnish represents an alternative material whose effects on salivary characteristics require further clinical evaluation. Saliva contributes to oral homeostasis through its buffering capacity, lubrication, and clearance functions. Salivary pH and flow rate are relevant indicators of the oral environment, while Streptococcus mutans is associated with the development of dental caries.
This randomized controlled clinical trial will compare the effects of a single application of bioactive glass varnish with those of fluoride varnish in children. The study is designed to assess changes in selected salivary parameters over a six-month follow-up period, including both an early assessment and a later assessment following treatment.
Unstimulated saliva samples will be collected at baseline before varnish application and at the scheduled follow-up visits. Collection will take place between 9:00 and 11:00 a.m. to maintain consistency in sampling conditions. Salivary pH will be measured using a calibrated digital pH meter. Salivary flow rate will be calculated from the volume of unstimulated saliva collected over five minutes. Salivary Streptococcus mutans levels will be determined by microbiological culture on Mitis Salivarius Bacitracin agar, with bacterial counts expressed as colony-forming units per milliliter.
The longitudinal measurements will be evaluated to examine changes in salivary parameters over time and differences between the two treatment groups. The findings will provide comparative clinical data on the effects of bioactive glass varnish and fluoride varnish on selected salivary parameters in children and may help inform further research into bioactive materials for preventive dental care.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Pharos University in Alexandria is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
History of systemic illness or medication affecting salivary secretion
Other: Bioactive glass topical varnish
Other: Fluoride varnish
topical preventive measure to resist dental caries
traditional preventive measure to dental caries
Change in Salivary Streptococcus mutans Count from Baseline (CFU/mL)
Time frame: 6 months
Change in Unstimulated Salivary Flow Rate from Baseline
Time frame: 6 months
Change in Unstimulated Salivary pH from Baseline
Time frame: 6 months
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 2 months is below that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pharos University in Alexandria