Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

Study Overview
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Brief Summary
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Difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (MIH) is a frequently reported clinical problem. The effect of low-level laser on the efficacy of anesthesia in teeth with MIH has not been studied yet. Aim of this study is to evaluate the effect of the Photobiomodulation on the efficacy of anesthesia of maxillary permanent molar teeth with MIH. Design: The current study was conducted as a prospective, parallel-arm control, randomized, triple-blind clinical trial in children aged between 7to12 years. Maxillary permanent molar teeth with MIH requiring pulpotomy treatment were included. 70 participants were divided randomly into 2 groups as experiment (with PBMT) and control (Placebo) according to the anesthesia technique. In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. Evaluation of the pain scores were performed during the access cavity preparation of the pulpotomy treatment using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Also, additional anesthesia requirements were assessed for both groups while working on the dentin and pulp

Official Title
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Evaluation of the Effect of the Photobiomodulation on the Efficacy of Anesthesia of Maxillary Permanent Molar Teeth With MIH

Conditions
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Low-level-laser Theraphy, Anesthesia, Local, Molar Incisor Hypomineralization

Intervention / Treatment
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* Procedure: Photobiomodulation
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Molar Incisor Hypoplasia (MIH) Maxillary permanent first molars with MIH Must be the score 3 of MIH (European Academy of Paediatric Dentistry MIH diagnostic criteria Exclusion Criteria: The teeth showing irreversible pulp pathology (according to the American Association of Endodontics) The children who had negative or definitely negative behavior Allergy to local anesthetics Taking any medication that might affect the anesthetic assessment

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation group<br>In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). | Procedure: Photobiomodulation<br>* In experimental groups, before topical anesthesia, PBMT was applied by utilizing a diode laser (EpiX; Biolase technology, inc., USA) with a continuous wavelength of 940 nm on a 400-μm fiber with only biostimulation properties. In accordance with the recommendations of the device's manufacturer, it was applied using circular motions in a manner as slowly as possible (an average of 33-36 circular movements in 60 s)<br>|
| Placebo Comparator: Placebo Group<br>In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. | Procedure: Placebo<br>* In the control group (placebo), the laser probe was directed to the mucosa for (buccal and palatal area), but not activated, and the sound of the laser device previously recorded on the mobile telephone was played for the same time of experimental group in order to provide similar conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale | Anesthesia efficacy was evaluated objectively with the FLACC scale during the cavity preparation. Behavioral parameters were recorded during the cavity preparation (dentin cutting handpiece ) FLACC scale comprises of five sub-parameters. They are Face, Legs, Activity, Crying and Consolability. Each sub-parameter is given a pain score of 0 to 2. So total behavioral pain score range 0-10 as follows: 0 = relaxed and comfortable (no pain); 1-3= mild discomfort; 4-6 = moderate pain; and 7-10 = severe discomfort and/or pain. Success was achieved if patients experienced mild pain or no pain during the preparation of the cavity | Through study completion, an average of 24 weeks | 
| Evaluating need of supplementary anesthesia | The subjects with moderate/higher pain need supplementary anesthesia | Through study completion, an average of 24 weeks |