Efficacy of Er,Cr:YSGG Laser in Partial Pupotomy

July 5, 2019 updated by: Merve Erkmen Almaz

Evaluation of the Efficacy of Er,Cr:YSGG Laser in Partial Pulpotomy Therapy of Permanent Immature Molar Teeth With Deep Dentin Caries

The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were included in the study. According to the treatment, the teeth were randomly divided into two groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement and composite resin. In the laser+MTA group, the treatment procedures were the same as the MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area after bleeding control to provide biostimulation. Patients were called for followup appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kırıkkale, Turkey, 71200
        • Kırıkkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of immature molar tooth with deep dentin caries.

Exclusion Criteria:

History of any systematic disease Uncompliance with dental treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laser+MTA group
before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area
Procedure: Partial pulpotomy with laser+MTA
After removing caries, laser+MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.
ACTIVE_COMPARATOR: MTA group
MTA was applied to the exposed area
Procedure: Partial pulpotomy with MTA
After removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of spontaneous pain, percussion, palpation, mobility, presence of fistula, swelling of the mucosa, loss of lamina dura, internal or external root resorption and periapical radiolucency
Time Frame: First, third, sixth and twelfth month
Presence of pathological findings were scored as 1, absence was scored as 0
First, third, sixth and twelfth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merve Erkmen Almaz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2018

Primary Completion (ACTUAL)

January 14, 2019

Study Completion (ACTUAL)

January 14, 2019

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (ACTUAL)

July 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KirikkaleUni

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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