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Not Yet Recruiting NCT07826130

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

Conditions: Molar-Incisor Hypomineralization (MIH)

Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Ain Shams University

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Children who are physically or mentally disabled or who have a medical condition that may complicate treatment. * Reported allergy to silver or any material included in the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07826130). StuddyBuddy aggregates publicly available trial information.