About this trial
This study aims to evaluate and compare the remineralizing and antimicrobial effects of nano silver fluoride and bioactive glass gel on primary teeth exposed to therapeutic radiation. The study includes both in vitro and in vivo components. The clinical component will include 30 pediatric patients aged 6-10 years undergoing therapeutic head and neck radiotherapy. Participants will be randomly allocated into two groups to receive either nano silver fluoride or bioactive glass gel. The effects of the interventions will be evaluated using salivary pH and bacterial count measurements. The laboratory component will evaluate changes in irradiated primary tooth enamel, including surface morphology, mineral content, and microhardness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients undergoing therapeutic head and neck radiotherapy.
Age 6 to 10 years.
Presence of at least one sound primary tooth.
The oral cavity lies within the radiotherapy field during treatment.
Disqualifiers
Systemic diseases affecting tooth mineralization.
Use of medications known to influence salivary flow or enamel integrity, other than radiotherapy.
Edentulous upper and lower jaws.
Extensive dental caries or severe enamel defects.
Trial design
Parallel
Treatments tested in this trial
Nano Silver Fluoride
Other interventionNano silver fluoride solution will be topically applied once for 1 minute
Bioactive Glass Gel
Other interventionBioactive glass gel will be topically applied once daily for 1 minute for 7 consecutive days
Treatment groups
Trial outcomes
Primary outcomes
Change in Salivary Bacterial Count
Salivary bacterial count will be measured to evaluate the antimicrobial effect of nano silver fluoride compared with bioactive glass gel.
Change in Salivary pH
Salivary pH will be measured before and after the intervention to evaluate changes following treatment with nano silver fluoride or bioactive glass gel
Sponsors and contacts
Click on the lead sponsor to view all of their trials.