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HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN

Molar Incisor Hypomineralization Clinical Trial

Official title:
MANAGEMENT OF HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN (RANDOMIZED CLINICAL TRIAL)

Clinical Trial Summary

Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. A sample of children having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH). All selected 45 first permanent molars will be randomly equally allocated into three groups. DH will be evaluated after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10).

Clinical Trial Description

Background: Molar Incisor Hypomineralisation (MIH) is a qualitative defect of enamel that shows asymmetrically involvement of one to four on first permanent molars (FPM) with or without incisor teeth involvement. Hypersensitivity is one of the biggest challenges in the treatment of MIH. Aim of the study: To evaluate the effectiveness of photo biomodulation (PBM) with low-level laser therapy (LLLT) in the management of hypersensitivity in children diagnosed with MIH in comparison to resin-based fissure sealant (Fissured Novo Plus) and glass ionomer sealant (Ketac) and the impact of LLLT on their oral health-related quality of life (OHRQoL). Materials and Method: A sample of children with an age range of 8-10 years old, having a first permanent molar erupted with MIH and suffering of dentin hypersensitivity (DH), will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. All selected 45 first permanent molars will be randomly equally allocated into three groups. Group 1(n=15): PBM with LLLT, Group 2 (n=15): Resin-based sealant (Fissured Nova Plus) and Group 3 (n=15): Glass ionomer sealant (Ketac). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment. OHRQoL will be also assessed for all children through the child perceptions questionnaire (CPQ8-10) which will be administered at the beginning and the end of the treatment. Results: The data will be collected, tabulated, and analyzed using suitable statistical tests to achieve the aim of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06154733
Study type Interventional
Source Alexandria University
Contact
Status Not yet recruiting
Phase N/A
Start date January 2024
Completion date January 2025
View Details
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