Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

Not Applicable

Completed

• Conditions: Low-level-laser Theraphy; Molar Incisor Hypomineralization; Anesthesia, Local
• Interventions: Procedure: Placebo; Procedure: Photobiomodulation

• Registration Number: NCT05344014
• Lead Sponsor: Kocaeli University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-11
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-19
• Last Update Submitted: 2022-04-19
• Study First Posted: 2022-04-25
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated.
Photobiomodulation group	Photobiomodulation	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).

Primary Outcome Measures

Name	Time	Method
Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale	Through study completion, an average of 24 weeks	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
Evaluating need of supplementary anesthesia	Through study completion, an average of 24 weeks	The subjects with moderate/higher pain need supplementary anesthesia

Trial Locations

Locations (1)

Kocaeli University Faculty of Dentistry; 🇹🇷 Kocaeli, Turkey