HYPERSENSITIVITY IN MOLAR INCISOR HYPOMINERALISATION USING LOW LEVEL LASER IN CHILDREN

Study Overview
=================
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.

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

Conditions
-----------------
Molar Incisor Hypomineralization

Intervention / Treatment
-----------------
* Procedure: Photobiomodulation usinf low level laser therapy
* Procedure: Resin-based sealant
* Procedure: Glass ionomer sealant


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation with low level laser therapy<br>This group will be subjected to photo biomodulation by low level laser therapy. Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions. During the laser treatments, both the volunteer and operator will use protective eyewear and all rules of safety will be obeyed. | Procedure: Photobiomodulation usinf low level laser therapy<br>* Diode laser will be used (SIROLaser Blue®, Sirona, Germany) at a wavelength of 660 nm and a power of 100 mW for 10 sec, corresponding to an energy dose of 1 J. Irradiation will be performed at the hypomineralized area: two irradiations scanning the surface in the mesiodistal direction and two in the occlusogingival direction (perpendicular to the tooth surface) precisely over the lesion, in a uniform scanning motion with relative isolation. Treatment will be performed in 3 sessions with a 72-hour interval between sessions.<br>|
| Active Comparator: light cured resin-based sealant<br>This group will receive light cured resin-based sealant (Fissured Novo Plus). Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. | Procedure: Resin-based sealant<br>* Cotton rolls and a four-handed technique will be applied for isolation. Scotchbond Universal will be rubbed in the cleaned surface for 20 seconds and air dried for 5 seconds. Afterwards, Fissured Novo Plus will be applied with a syringe. Before light-curing, the presence of air bubbles will be checked and teased out. Light curing for 40 seconds will be done. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs.<br>|
| Active Comparator: glass ionomer sealant<br>This group will receive glass ionomer sealant. Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. | Procedure: Glass ionomer sealant<br>* Fuji triage will be applied after activating and mixing the capsule. Light cure for 20 seconds. Occlusion will be checked using articulating paper and necessary adjustments will be done using finishing burs. For the duration of the study, children will be instructed to undergo regular tooth brushing and flossing. Any other needed treatment will be done for the child.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin Hypersensitivity | it will be measures usinf a Faces pain scale | Day0, 1 week, 1 month, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health related Quality of life (OHRQoL) | OHRQoL will be assessed for all children through the validated Arabic version of the Child Perceptions Questionnaire (CPQ8-10)which will be administered at the beginning and the end of the treatment. The questionnaire evaluates the severity of oral symptoms, functional limitations as well as emotional and social well-being. The questions are measured using a 5-point Likert scale as follows: never = 0, once or twice = 1, sometimes = 2, often = 3, and Every day or almost every day = 4. Hence, total scores range from 0 to100, and higher scores indicate poorer OHRQoL. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Molar Incisor Hypomineralisation, Low Level Laser, Sealant, Hypersensitivity