Clinical trial NCT06154733: HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN
Official title: MANAGEMENT OF HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN (RANDOMIZED CLINICAL TRIAL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: Molar Incisor Hypomineralisation, Low Level Laser, Sealant, Hypersensitivity
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All selected 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).
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 6-10-year-old children (15).
* At least one tooth with MIH and DH reported in the occlusal region with sensitivity equal to or greater than 4 on the Visual analogue Scale (VAS).
* Good overall health (ASA I).

Exclusion Criteria:

* First permanent molars with active carious lesions or defective restorations
* Sufficient dentin loss that requires restorative therapy.
* Any clinical signs of failure (abscess, fistula).
* Patients with systemic diseases.
* Having undergone any professional desensitizing treatment in the previous 6 months.
* Having used a desensitizing paste in the previous 3 months.
* Use of anti-inflammatory drugs or analgesics at the time of recruitment.

Primary outcomes:
measure: Dentin Hypersensitivity
timeFrame: Day0, 1 week, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Oral health related Quality of life (OHRQoL)
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References: