Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars

ConditionMolar-Incisor Hypomineralization (MIH)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-12

SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 7-12 years diagnosed with molar-incisor hypomineralization (MIH) in first permanent molars according to the European Academy of Paediatric Dentistry (EAPD) criteria.

MIH-affected teeth exhibiting demarcated opacity, post-eruptive structural loss of enamel, and hypersensitivity (Treatment Need Index = 4).

Children who are able to cooperate during treatment and attend scheduled follow-up visits.

Children whose parents or legal guardians provide informed consent for participation in the study.

Disqualifiers

Hypomineralized molars caused by other conditions, including syndromes, fluorosis, enamel hypoplasia, amelogenesis imperfecta, or dental caries.

Teeth with defective restorations or pulpal symptoms.

History of desensitizing treatment within the previous 6 months.

Use of anti-inflammatory drugs or analgesics at the time of recruitment.

Trial design

Design model

Parallel

Treatments tested in this trial

Nano Silver Fluoride
Other intervention
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.
Photobiomodulation Therapy
Other intervention
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.
Pre-appointment analgesics
Drug
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.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Nano Silver FluorideExperimental treatment 1 intervention

Group B: Photobiomodulation TherapyExperimental treatment 1 intervention

Group C: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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