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Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

NCT05344014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-04-25

No results posted yet for this study

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

Conditions

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

Interventions

PROCEDURE

Photobiomodulation

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)

PROCEDURE

Placebo

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

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344014 on ClinicalTrials.gov