Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

NCT ID: NCT05344014

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-04-01

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Photobiomodulation group

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).

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: PROCEDURE

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)

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

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

Interventions

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)

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Ulku Sermet Elbay

Assoc.Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University Faculty of Dentistry

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Topcuoglu HS, Akpinar B. The effect of low-level laser therapy on the success rate of inferior alveolar nerve blocks in mandibular molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2021 Oct;54(10):1720-1726. doi: 10.1111/iej.13596. Epub 2021 Aug 2.

Reference Type: BACKGROUND

PMID: 34241896 (View on PubMed)

Ghabraei S, Chiniforush N, Bolhari B, Aminsobhani M, Khosarvi A. The Effect of Photobiomodulation on the Depth of Anesthesia During Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis (Double Blind Randomized Clinical Trial). J Lasers Med Sci. 2018 Winter;9(1):11-14. doi: 10.15171/jlms.2018.03. Epub 2017 Dec 26.

Reference Type: BACKGROUND

PMID: 29399304 (View on PubMed)

Menoncin BLV, Portella PD, Ramos BLM, Assuncao LRDS, de Souza JF, Menezes JVNB. Dental anxiety in schoolchildren with molar incisor hypomineralization-A population-based cross-sectional study. Int J Paediatr Dent. 2019 Sep;29(5):615-623. doi: 10.1111/ipd.12503. Epub 2019 May 6.

Reference Type: BACKGROUND

PMID: 31009135 (View on PubMed)

Other Identifiers

KAEK/04.bI.05

Identifier Type: -

Identifier Source: org_study_id