Nano-Silver Versus Bioactive Glass for Primary Teeth Exposed to Therapeutic Radiation

NCT07866482 — Not applicable, Recruiting, 30 participants, Faculty of Dental Medicine for Girls

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Antimicrobial and Remineralization Efficacy of Nano-Silver Versus Bioactive Glass on Primary Teeth Exposed to Therapeutic Radiation

RegistryNCT07866482
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment30 (Estimated)
SponsorFaculty of Dental Medicine for Girls (Other gov)
ConditionsRadiation Caries
InterventionsNano Silver Fluoride, Bioactive Glass Gel (Other)
Datesstart 2026-07-11, primary completion 2026-12-31 (estimated), completion 2027-02-15 (estimated), first posted 2026-10-08, last updated 2026-10-08
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Radiation Caries All trials of Nano Silver Fluoride All trials of Bioactive Glass Gel

-Summary

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.

Expand all sections  ·  Collapse all

+Detailed description

The study consists of in vitro and in vivo components designed to evaluate the effects of therapeutic radiation on primary teeth and to compare the effects of nano silver fluoride and bioactive glass gel.

For the in vitro component, 12 sound extracted primary molars will be sectioned mesiodistally to obtain 24 enamel specimens. The specimens will be exposed to therapeutic radiation and randomly assigned to two groups. One group will receive nano silver fluoride solution, while the other will receive bioactive glass gel. Enamel specimens will be evaluated at baseline, after radiation exposure, and after application of the assigned material. Assessments will include scanning electron microscopy for surface morphology, energy-dispersive X-ray spectroscopy for mineral analysis, and Vickers microhardness testing.

For the in vivo component, 30 pediatric patients undergoing therapeutic head and neck radiotherapy will be randomly allocated into two groups of 15 participants. The first group will receive a single application of nano silver fluoride solution for one minute. The second group will use bioactive glass gel once daily for one minute for seven days. Clinical assessment will include measurement of salivary pH and bacterial counts before and after application of the assigned intervention.

+Arms and interventions

ArmTypeInterventionsDescription
Nano Silver FluorideExperimentalOther: Nano Silver FluorideParticipants will receive a single application of nano silver fluoride solution for 1 minute.
Bioactive Glass GelExperimentalOther: Bioactive Glass GelParticipants will receive bioactive glass gel once daily for 1 minute for 7 days
  • Nano Silver Fluoride (Other), also known as nano silver flouride: Nano silver fluoride solution will be topically applied once for 1 minute
  • Bioactive Glass Gel (Other): Bioactive glass gel will be topically applied once daily for 1 minute for 7 consecutive days

+Outcome measures

Primary outcomes

  • Change in Salivary Bacterial Count [Baseline and 1 week after intervention]: Salivary bacterial count will be measured to evaluate the antimicrobial effect of nano silver fluoride compared with bioactive glass gel.
  • Change in Salivary pH [Baseline and 1 week after intervention]: Salivary pH will be measured before and after the intervention to evaluate changes following treatment with nano silver fluoride or bioactive glass gel

+Eligibility

Sex: All, ages: 6 Years to 10 Years

Inclusion Criteria:

* 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.
* Written informed consent obtained from a parent or legal guardian.

Exclusion Criteria:

* 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.
* Habitual mouth breathing.
* Uncooperative patients or lack of parental consent.

+Locations (1)

FacilityCityCountryStatus
National Cancer Institute, Cairo UniversityCairo, Cairo GovernorateEgyptRecruiting