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Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation) (MIH)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Photobiomodulation
Placebo
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-level-laser Theraphy

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts 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

Sites / Locations

  • Kocaeli University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Photobiomodulation group

Placebo Group

Arm 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).

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

Outcomes

Primary Outcome Measures

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
Evaluating need of supplementary anesthesia
The subjects with moderate/higher pain need supplementary anesthesia

Secondary Outcome Measures

Full Information

First Posted
April 12, 2022
Last Updated
April 19, 2022
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT05344014
Brief Title
Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)
Acronym
MIH
Official Title
Evaluation of the Effect of the Photobiomodulation on the Efficacy of Anesthesia of Maxillary Permanent Molar Teeth With MIH
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-level-laser Theraphy, Anesthesia, Local, Molar Incisor Hypomineralization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation group
Arm Type
Experimental
Arm 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).
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated.
Intervention Type
Procedure
Intervention Name(s)
Photobiomodulation
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Description
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
Time Frame
Through study completion, an average of 24 weeks
Title
Evaluating need of supplementary anesthesia
Description
The subjects with moderate/higher pain need supplementary anesthesia
Time Frame
Through study completion, an average of 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Kocaeli University Faculty of Dentistry
City
Kocaeli
ZIP/Postal Code
41190
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34241896
Citation
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.
Results Reference
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PubMed Identifier
29399304
Citation
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.
Results Reference
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PubMed Identifier
31009135
Citation
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.
Results Reference
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Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

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