ClinicalTrials.Veeva

Menu

Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

K

Kocaeli University

Status

Completed

Conditions

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

Treatments

Procedure: Placebo
Procedure: Photobiomodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05344014
KAEK/04.bI.05

Details and patient eligibility

About

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

Enrollment

70 patients

Sex

All

Ages

7 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems