Radiation CariesNCT07866482
Nano-Silver Versus Bioactive Glass for Primary Teeth Exposed to Therapeutic Radiation
A study testing Nano Silver Fluoride and Bioactive Glass Gel in people with Radiation Caries, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Radiation Caries
- What is being tested?
- Nano Silver Fluoride and Bioactive Glass Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute, Cairo University
Cairo, Cairo Governorate, 11796
Eman Eldebawy, professor, +20 112 226 0379, Eman_Eldebawy@gmail.com
About this study
Official title: Antimicrobial and Remineralization Efficacy of Nano-Silver Versus Bioactive Glass on Primary Teeth Exposed to Therapeutic Radiation
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.
Read the 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.
- Conditions
- Radiation Caries
- Being tested
- Nano Silver Fluoride, Bioactive Glass Gel
- Keywords
- Radiation Caries, Primary Teeth, Head and Neck Radiotherapy, Nano Silver Fluoride, Bioactive Glass, Enamel Remineralization, Pediatric Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Silver FluorideOther
Also called nano silver flouride
Nano silver fluoride solution will be topically applied once for 1 minute
Bioactive Glass GelOther
Bioactive glass gel will be topically applied once daily for 1 minute for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Nano Silver Fluoride | Experimental | Participants will receive a single application of nano silver fluoride solution for 1 minute. Receives: Other: Nano Silver Fluoride |
| Bioactive Glass Gel | Experimental | Participants will receive bioactive glass gel once daily for 1 minute for 7 days Receives: Other: Bioactive Glass Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 week after intervention
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
Measured: Baseline and 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start11 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation 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
- Model description
- Participants will be randomly allocated in parallel to two intervention groups (15 participants per group)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, somia mohamed refat mostafa selim, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866482
- Sponsor's protocol ID
- P-PE-26-06
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial and Remineralization Efficacy of Nano-Silver Versus Bioactive Glass on Primary Teeth Exposed to Therapeutic Radiation
- ClinicalTrials.gov ID
- NCT07866482
- Acronym / sponsor ID
- P-PE-26-06
- Conditions
- Radiation Caries
- Keywords
- Radiation Caries, Primary Teeth, Head and Neck Radiotherapy, Nano Silver Fluoride, Bioactive Glass, Enamel Remineralization, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 11 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in parallel to two intervention groups (15 participants per group)
| Arm | Type | Receives |
|---|---|---|
| Nano Silver Fluoride | Experimental | Other: Nano Silver FluorideParticipants will receive a single application of nano silver fluoride solution for 1 minute. |
| Bioactive Glass Gel | Experimental | Other: Bioactive Glass GelParticipants will receive bioactive glass gel once daily for 1 minute for 7 days |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano Silver FluorideAlso: nano silver flourideNano silver fluoride solution will be topically applied once for 1 minute | Other | Nano Silver Fluoride |
| Bioactive Glass GelBioactive glass gel will be topically applied once daily for 1 minute for 7 consecutive days | Other | Bioactive Glass Gel |
Primary outcome
Change in Salivary Bacterial Count
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Related trials for Radiation Caries
Enrolling by invitationPhase 4
Can SAP P11-4 Affect The Appearance of Interproximal Cavities on an X-ray in a Military Population
Incipient Interproximal Caries
Active, not recruitingObservational study
Longitudinal Oral Health Changes After Head and Neck Radiotherapy
Head & Neck Cancer, Head & Neck Squamous Cell Carcinoma
Not yet recruiting
Evaluation of Radiation-Free Caries Detection Integrated Into Intraoral Scanners Compared With Conventional Diagnostic Methods
Caries Assessment, Caries; Dentin
Recruiting
Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
Caries,Dental
Not yet recruitingPhase 2
The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in NPC Patients
Sodium Fluoride
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano Silver Fluoride and Bioactive Glass Gel in people with Radiation Caries, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Bacterial Count (time frame: Baseline and 1 week after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.