- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04044989
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
-
-
-
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).
|
Diode laser device was used for photobiomodulation
LED device was used for photobiomodulation
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).
|
Diode laser device was used for photobiomodulation
LED device was used for photobiomodulation
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
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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