Investigation of the Photobiomodulation Applications
Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor. When literature studies are examined, different studies have been performed on Laser and LED applications, however, the lack of a study that evaluates and compares the effectiveness of these methods in terms of clinical and biochemical parameters. The aim of this study is to compare the effects of laser and LED applications on tooth movement speed and to investigate the effects of these applications on the gingival fluid IL-8, OPG, RANKL. Total of 24 patients with maxillary first-premolar extraction orthodontic treatment will be included in this study, and this study will consist of 3 groups, Laser, LED and placebo group. The laser will be applied on days 0,3,7,14,21,28,35, take impression of teeth and gingival fluid samples will be collected in these days. LED group will be given 10 minutes LED for 30 days, taken impression and DOS samples will be collected on specified days. In the placebo group, the non-active pulse laser light will be kept in the teeth and the patients will not know which group in they are. Thus, the psychological dimension of the applications will be eliminated. Sampling will be done for the placebo group on the days determined. The investigator's project proposal consists of a total of 5 work packages; Determination of patient groups in the 1st stage and obtaining consent forms, 2nd stage Photobiomodulation applications (laser, LED, placebo application), 3rd stage orthodontic measurement and evaluation of these measurements 3D environment, taking gingival fluid samples in the 4th stage and evaluating them biochemically. In the 5th stage, statistical analysis and evaluation of the results will be done. The data will be evaluated with SPSS 21.0.In this study, it is tried to reduce the time spent in the orthodontic treatment to close the extraction area. In this way, it will contribute to economy and time saving in terms of all orthodontic treatment physicians and physicians. It will illuminate the application of LED device which is more advantageous in terms of cost and space gain in clinical practice of physicians.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedJuly 18, 2019
July 1, 2019
1 month
July 10, 2019
July 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Orthodontic tooth movement Change
Measurement of orthodontic tooth movement (mm)
1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Secondary Outcomes (7)
Gingival Index Change
1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Plaque Index Change
1st, 3rd, 7th, 14th, 21th, 28th, 35th day
RANKL Change
1st, 3rd, 7th, 14th, 21th, 28th, 35th day
OPG Change
1st, 3rd, 7th, 14th, 21th, 28th, 35th day
IL-8 Change
1st, 3rd, 7th, 14th, 21th, 28th, 35th day
- +2 more secondary outcomes
Study Arms (3)
Tooth Movement
EXPERIMENTALCanine distalization on premolar extracted patients
Biochemistry measurements
EXPERIMENTALbiochemistry analysis of IL-8, OPG, RANKL
periodontal measurements
EXPERIMENTALgingival and plaque index, blooding on probing, pocket depth
Interventions
810 nm GaAlAs diode laser device
850 nm LED (light emitting diode)
810 nm GaAlAs diode laser device
Eligibility Criteria
You may qualify if:
- adequate oral hygiene
- Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment
- lack of congenital missing teeth in upper jaw
- no systemic disease
You may not qualify if:
- patients who wish to discontinue treatment
- patients who cannot provide oral hygiene
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY CHAIR
Hasan Gundogar, PhD
Gaziantep University Periodontology Department
- STUDY CHAIR
Seyithan Taysi, Prof
Gaziantep University Biochemistry Department
Central Study Contacts
Aslihan Karakas, MS
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Orthodontics
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 17, 2019
Study Start
August 1, 2019
Primary Completion
September 1, 2019
Study Completion
February 1, 2020
Last Updated
July 18, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share