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Clinical Trials/NCT04022252
NCT04022252UnknownNot Applicable

Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement

University of Gaziantep0 sites24 target enrollmentStarted: August 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
24
Primary Endpoint
Orthodontic tooth movement Change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Tooth Movement

Experimental

Canine distalization on premolar extracted patients

Intervention: Cheese dental laser (Device)

Tooth Movement

Experimental

Canine distalization on premolar extracted patients

Intervention: OrthoPulse (Device)

Tooth Movement

Experimental

Canine distalization on premolar extracted patients

Intervention: Placebo (Other)

Biochemistry measurements

Experimental

biochemistry analysis of IL-8, OPG, RANKL

Intervention: Cheese dental laser (Device)

Biochemistry measurements

Experimental

biochemistry analysis of IL-8, OPG, RANKL

Intervention: OrthoPulse (Device)

Biochemistry measurements

Experimental

biochemistry analysis of IL-8, OPG, RANKL

Intervention: Placebo (Other)

periodontal measurements

Experimental

gingival and plaque index, blooding on probing, pocket depth

Intervention: Cheese dental laser (Device)

periodontal measurements

Experimental

gingival and plaque index, blooding on probing, pocket depth

Intervention: OrthoPulse (Device)

periodontal measurements

Experimental

gingival and plaque index, blooding on probing, pocket depth

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Orthodontic tooth movement Change

Time Frame: 1st, 3rd, 7th, 14th, 21th, 28th, 35th day

Measurement of orthodontic tooth movement (mm)

Secondary Outcomes

  • OPG Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • Bleeding on Probing Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • 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)
  • IL-8 Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)
  • Periodontal Pocket Depth Change(1st, 3rd, 7th, 14th, 21th, 28th, 35th day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merve Goymen

Head of Orthodontics

University of Gaziantep

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