Prevention of Dental CariesNCT07875387
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
A study testing Bioactive glass topical varnish and Fluoride varnish in people with Prevention of Dental Caries, run by Pharos University in Alexandria.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Dental Caries
- What is being tested?
- Bioactive glass topical varnish and Fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children with no active dental caries or oral lesions
- Normal salivary flow rate
- Willingness to participate
Who cannot join
- • History of systemic illness or medication affecting salivary secretion
- Recent use (within 1 month) of antibiotics, mouthwash, or fluoride varnish
About this study
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.
Read the detailed description
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.
- Conditions
- Prevention of Dental Caries
- Being tested
- Bioactive glass topical varnish, Fluoride varnish
- Keywords
- Bioactive glass varnish, Fluoride varnish, Salivary Streptococcus mutans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive glass topical varnishOther
topical preventive measure to resist dental caries
Fluoride varnishOther
traditional preventive measure to dental caries
| Study group | Role | What they receive |
|---|---|---|
| fluoride varnish | Active comparator | Not described Receives: Other: Bioactive glass topical varnish |
| Bioactive glass varnish | Experimental | Not described Receives: Other: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Streptococcus mutans Count from Baseline (CFU/mL)
Measured: 6 months
Change in Unstimulated Salivary Flow Rate from Baseline
Measured: 6 months
Change in Unstimulated Salivary pH from Baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inas Mahmoud Karawia, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875387
- Sponsor's protocol ID
- 02-2026-08-4-3-556
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No