Clinical trial NCT04022252: Investigation of the Photobiomodulation Applications
Official title: Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Tooth Movement
Keywords: orthodontics
tooth movement
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 24
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* adequate oral hygiene
* Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment
* lack of congenital missing teeth in upper jaw
* no systemic disease

Exclusion Criteria:

* patients who wish to discontinue treatment
* patients who cannot provide oral hygiene

Primary outcomes:
measure: Orthodontic tooth movement Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Secondary outcomes:
measure: Gingival Index Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
measure: Plaque Index Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
measure: RANKL Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
measure: OPG Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
measure: IL-8 Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
measure: Bleeding on Probing Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
measure: Periodontal Pocket Depth Change
timeFrame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Other outcomes:
Locations:
Study officials:
affiliation: Gaziantep University Periodontology Department
name: Hasan Gundogar, PhD
role: STUDY_CHAIR
affiliation: Gaziantep University Biochemistry Department
name: Seyithan Taysi, Prof
role: STUDY_CHAIR
References: