Investigation of the Photobiomodulation Applications

Orthodontic Tooth Movement Clinical Trial

Official title:

Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04022252
• Other study ID #: 261
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: February 2020

Study information

• Verified date: July 2019
• Source: University of Gaziantep
• Contact: Merve Goymen, PhD
• Phone: +905054767651
• Email: mervegoymen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: February 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Tooth Movement

Intervention

Device:
• Cheese dental laser
810 nm GaAlAs diode laser device
• OrthoPulse
850 nm LED (light emitting diode)

Other:
• Placebo
810 nm GaAlAs diode laser device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orthodontic tooth movement Change	Measurement of orthodontic tooth movement (mm)	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Secondary	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
Secondary	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
Secondary	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
Secondary	OPG Change	Analyses of OPG in gingival crevicular fluid	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Secondary	IL-8 Change	Analyses of IL-8 in gingival crevicular fluid	1st, 3rd, 7th, 14th, 21th, 28th, 35th day
Secondary	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
Secondary	Periodontal Pocket Depth Change	Measurement of Periodontal Pocket Depth (mm)	1st, 3rd, 7th, 14th, 21th, 28th, 35th day