Photobiomodulation and Root Resorption

August 1, 2019 updated by: Merve Goymen, University of Gaziantep

Placebo-Controlled, Randomized, Double Blind Trial of Effect of Photobiomodulation Therapies On The Root Resorption Associated With Orthodontic Forces: A Pilot Study Using Micro Computed Tomography

Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the …………. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
      • Gaziantep, Turkey
        • Gaziantep 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

15 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No history of orthodontic treatment
  • No systemic disease or craniofacial anomaly
  • No dental trauma and tooth with root resorption
  • Having good oral hygiene
  • No periodontal disease (no more than 3mm pocket)
  • No restored or endodontically untreated upper right 1st premolar teeth
  • Having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment

Exclusion Criteria:

  • Problems in patient compliance
  • Inadequate oral hygiene
  • Development of any medical problem making orthodontic treatment contraindicated during the study period

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Root resorption (total)
The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).
Device: Laser
Diode laser device was used for photobiomodulation
Device: light-emitting diode (LED)
LED device was used for photobiomodulation
Device: Placebo
Diode laser device was used for placebo effect
Experimental: Root resorption (local)
The resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT).
Device: Laser
Diode laser device was used for photobiomodulation
Device: light-emitting diode (LED)
LED device was used for photobiomodulation
Device: Placebo
Diode laser device was used for placebo effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root Resorption
Time Frame: through study completion, an average of 4 weeks
Crater volume measurement
through study completion, an average of 4 weeks

Collaborators and Investigators

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

Sponsor

University of Gaziantep

Investigators

  • Principal Investigator: Aysegul Gulec, PhD, Gaziantep University Orthodontics Department
  • Study Chair: Merve Goymen, PhD, Gaziantep University Orthodontics Department

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 10, 2018

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

December 13, 2018

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 332 (NIHR School for Primary Care Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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