An interventional study of Nano Silver Fluoride and Photobiomodulation Therapy in Molar-Incisor Hypomineralization (MIH), sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Molar-incisor hypomineralization (MIH) is a developmental condition affecting primarily the first permanent molars and may be associated with post-eruptive enamel breakdown, hypersensitivity, and difficulties in achieving adequate pain control during dental treatment.
This randomized controlled trial will evaluate the effectiveness of nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing interventions applied before cavity preparation in children aged 7-12 years with MIH-affected first permanent molars with post-eruptive enamel breakdown. The study will compare the effects of NSF and PBMT with a control group receiving pre-appointment analgesics.
Hypersensitivity will be assessed using the Cumulative Hypersensitivity Index (CHI), while pain during cavity preparation and restoration will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring. All treated molars will receive glass ionomer cement restorations, which will subsequently be evaluated using the Modified United States Public Health Service (USPHS) criteria at 3, 6, and 12 months.
Molar-incisor hypomineralization (MIH) is a developmental condition primarily affecting the enamel of the first permanent molars. Affected teeth may exhibit demarcated opacities, post-eruptive structural loss of enamel, hypersensitivity, and difficulties during restorative treatment.
This study will evaluate the effect of using nano silver fluoride (NSF) and photobiomodulation therapy (PBMT) as desensitizing agents prior to cavity preparation in permanent molars affected by MIH with post-eruptive enamel breakdown.
A total of 45 children aged 7-12 years will be included and randomly assigned to three groups, with 15 participants in each group:
Group A: Nano silver fluoride (NSF). The affected molar will receive a single application of NSF 15 days before cavity preparation and restoration.
Group B: Photobiomodulation therapy (PBMT). The affected molar will receive PBMT 15 days before cavity preparation and restoration using a low-level diode laser with a wavelength of 980 nm and a power output of 100 mW.
Group C: Control group. Participants will receive oral hygiene instructions and pre-appointment analgesics before cavity preparation and restoration.
For the NSF group, hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days. For the PBMT group, hypersensitivity will similarly be assessed at baseline, 15 minutes after treatment, and after 15 days. The control group will undergo baseline assessment and receive the planned pre-appointment analgesic regimen.
At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
All molars will be restored using glass ionomer cement (GC Equia Forte HT). The restorations will be clinically evaluated at 3, 6, and 12 months using the Modified United States Public Health Service (USPHS) criteria.
The study will be conducted at the outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health and the Laser Unit, Faculty of Dentistry, Ain Shams University.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's planned enrollment of 45 is below the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration. The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration.
Other: Nano Silver Fluoride
Participants assigned to this group will receive photobiomodulation therapy (PBMT) 15 days before cavity preparation and restoration. A low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented. Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration.
Other: Photobiomodulation Therapy
Participants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
Drug: Pre-appointment analgesics
Participants assigned to this group will receive a single application of nano silver fluoride (NSF) to the affected first permanent molar 15 days before cavity preparation and restoration. The tooth will be isolated using cotton rolls and suction, and plaque or gross debris will be removed. A single drop of NSF solution will be dispensed into a plastic dappen dish and applied to the entire lesion using a disposable microbrush. Excess solution will be removed with a cotton swab. The solution will remain in contact with the tooth surface for 1 minute. Hypersensitivity will be assessed at baseline and 15 minutes after application, and again after 15 days before cavity preparation and restoration.
A low-level diode laser with a wavelength of 980 nm and a power output of 100 mW will be used. The laser tip will be positioned perpendicular to three points: mesial and distal to the cervical region and the central part of the tooth lesion or opacity. Each irradiation point will receive laser exposure for 20 seconds, delivering a total energy dose of 2 J. Standard laser safety measures, including protective eyewear for the patient and operator, will be implemented. Hypersensitivity will be assessed at baseline, 15 minutes after laser application, and again after 15 days before cavity preparation and restoration.
Participants assigned to the control group will receive oral hygiene instructions and a prescription for pre-appointment analgesics before cavity preparation and restoration. Hypersensitivity will be assessed at baseline. At the second visit, hypersensitivity will be reassessed, followed by conventional cavity preparation and restoration. Pain during the procedure will be evaluated using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
Pain During Cavity Preparation and Restoration
Pain during cavity preparation and restoration will be assessed using the Wong-Baker FACES Pain Rating Scale and pulse rate monitoring.
Time frame: During the cavity preparation and restoration procedure at the second visit, 15 days after application of the assigned desensitizing intervention.
Hypersensitivity
Hypersensitivity will be assessed using the Cumulative Hypersensitivity Index (CHI) at baseline, 15 minutes after application of the assigned intervention, and 15 days after intervention.
Time frame: Baseline, 15 minutes after intervention, and 15 days after intervention.
No study locations are listed for this record.
Plan to share: No
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