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
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
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
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
Learn more about this trial
Photobiomodulation and Root Resorption
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