Investigation of the Photobiomodulation Applications

Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement

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 Overview

• Status: Unknown
• Conditions: Orthodontic Tooth Movement
• Intervention / Treatment: Device: Cheese dental laser; Device: OrthoPulse; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tooth Movement; Canine distalization on premolar extracted patients	Device: Cheese dental laser; 810 nm GaAlAs diode laser device; Device: OrthoPulse; 850 nm LED (light emitting diode); Other: Placebo; 810 nm GaAlAs diode laser device
Experimental: Biochemistry measurements; biochemistry analysis of IL-8, OPG, RANKL	Device: Cheese dental laser; 810 nm GaAlAs diode laser device; Device: OrthoPulse; 850 nm LED (light emitting diode); Other: Placebo; 810 nm GaAlAs diode laser device
Experimental: periodontal measurements; gingival and plaque index, blooding on probing, pocket depth	Device: Cheese dental laser; 810 nm GaAlAs diode laser device; Device: OrthoPulse; 850 nm LED (light emitting diode); Other: Placebo; 810 nm GaAlAs diode laser device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthodontic tooth movement Change	Measurement of orthodontic tooth movement (mm)	1st, 3rd, 7th, 14th, 21th, 28th, 35th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index Change	Measurements of gingival index (according to Silness&Löe) all of teeth from 6 surface. Scale ranged from 0 to 3. All data will calculated for total mouth score.	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Plaque Index Change	Measurements of gingival index (according to Löe&Silness) all of teeth from 6 surface. Scale ranged from 0 to 3. All data will calculated for total mouth score.	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
RANKL Change	Analyses of RANKL level in gingival crevicular fluid. The analysis will perform via ELISA. Data will present "pg/30sn"	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
OPG Change	Analyses of OPG in gingival crevicular fluid	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
IL-8 Change	Analyses of IL-8 in gingival crevicular fluid	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Bleeding on Probing Change	Estimation of bleeding on probing. The reason for the Bleeding of Probing measurement is for the control of oral hygiene motivations in patients' follow-up.	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Periodontal Pocket Depth Change	Measurement of Periodontal Pocket Depth (mm)	1st, 3rd, 7th, 14th, 21th, 28th, 35th day

Collaborators and Investigators

• Sponsor: University of Gaziantep
• Investigators: Study Chair: Hasan Gundogar, PhD, Gaziantep University Periodontology Department; Study Chair: Seyithan Taysi, Prof, Gaziantep University Biochemistry Department

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: orthodontics; tooth movement
• Other Study ID Numbers: 261

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
• product manufactured in and exported from the U.S.: No