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Photobiomodulation and Root Resorption

Primary Purpose

Orthodontic Pathological Resorption of External Root, Orthodontic Appliance Complication, Orthodontic Tooth Movement

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laser
light-emitting diode (LED)
Placebo
Sponsored by
University of Gaziantep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontic Pathological Resorption of External Root focused on measuring photobiomodulation, laser, LED, resorption, micro-CT

Eligibility Criteria

15 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gaziantep University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Root resorption (total)

Root resorption (local)

Arm Description

The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

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).

Outcomes

Primary Outcome Measures

Root Resorption
Crater volume measurement

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
August 1, 2019
Sponsor
University of Gaziantep
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1. Study Identification

Unique Protocol Identification Number
NCT04044989
Brief Title
Photobiomodulation and Root Resorption
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Pathological Resorption of External Root, Orthodontic Appliance Complication, Orthodontic Tooth Movement
Keywords
photobiomodulation, laser, LED, resorption, micro-CT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Root resorption (total)
Arm Type
Experimental
Arm Description
The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).
Arm Title
Root resorption (local)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Laser
Intervention Description
Diode laser device was used for photobiomodulation
Intervention Type
Device
Intervention Name(s)
light-emitting diode (LED)
Intervention Description
LED device was used for photobiomodulation
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Diode laser device was used for placebo effect
Primary Outcome Measure Information:
Title
Root Resorption
Description
Crater volume measurement
Time Frame
through study completion, an average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysegul Gulec, PhD
Organizational Affiliation
Gaziantep University Orthodontics Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merve Goymen, PhD
Organizational Affiliation
Gaziantep University Orthodontics Department
Official's Role
Study Chair
Facility Information:
Facility Name
Gaziantep University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Photobiomodulation and Root Resorption

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