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NOT YET RECRUITING
NCT07826130
NA

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

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.

Official title: Effectiveness of Nano Silver Fluoride and Photobiomodualtion Therapy on Hypersensitivity and Pain During Cavity Preparation and The Restoration Outcomes in Molars Affected by Molar Incisor Hypomineralization: A Randomized Controlled Trial.

Key Details

Gender

All

Age Range

7 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2027-05-01

Completion Date

2028-12-01

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

OTHER

Nano Silver Fluoride

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

Photobiomodulation Therapy

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.

DRUG

Pre-appointment analgesics

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.