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

NCT07875387 | Not Yet Recruiting

• 1 other identifier: 02-2026-08-4-3-556
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prevention of Dental Caries

Keywords

Bioactive glass varnish; Fluoride varnish; Salivary Streptococcus mutans

Outcome Measures

Primary Outcomes (3)

• Change in Salivary Streptococcus mutans Count from Baseline (CFU/mL)

  6 months

• Change in Unstimulated Salivary Flow Rate from Baseline

  6 months

• Change in Unstimulated Salivary pH from Baseline

  6 months

Study Arms (2)

fluoride varnish

ACTIVE COMPARATOR

Other: Bioactive glass topical varnish

Bioactive glass varnish

EXPERIMENTAL

Other: Fluoride varnish

Interventions

Bioactive glass topical varnish OTHER

topical preventive measure to resist dental caries

fluoride varnish

Fluoride varnish OTHER

traditional preventive measure to dental caries

Bioactive glass varnish

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children with no active dental caries or oral lesions
• Normal salivary flow rate
• Willingness to participate

You may not qualify if:

• History of systemic illness or medication affecting salivary secretion
• Recent use (within 1 month) of antibiotics, mouthwash, or fluoride varnish

Sponsors & Collaborators

• Pharos University in Alexandria: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of dental public health and preventive dentistry

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10