Investigation of the Photobiomodulation Applications

NCT ID: NCT04022252

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Orthodontic Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tooth Movement

Canine distalization on premolar extracted patients

Group Type EXPERIMENTAL

Cheese dental laser

Intervention Type DEVICE

810 nm GaAlAs diode laser device

OrthoPulse

Intervention Type DEVICE

850 nm LED (light emitting diode)

Placebo

Intervention Type OTHER

810 nm GaAlAs diode laser device

Biochemistry measurements

biochemistry analysis of IL-8, OPG, RANKL

Group Type EXPERIMENTAL

Cheese dental laser

Intervention Type DEVICE

810 nm GaAlAs diode laser device

OrthoPulse

Intervention Type DEVICE

850 nm LED (light emitting diode)

Placebo

Intervention Type OTHER

810 nm GaAlAs diode laser device

periodontal measurements

gingival and plaque index, blooding on probing, pocket depth

Group Type EXPERIMENTAL

Cheese dental laser

Intervention Type DEVICE

810 nm GaAlAs diode laser device

OrthoPulse

Intervention Type DEVICE

850 nm LED (light emitting diode)

Placebo

Intervention Type OTHER

810 nm GaAlAs diode laser device

Interventions

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Cheese dental laser

810 nm GaAlAs diode laser device

Intervention Type DEVICE

OrthoPulse

850 nm LED (light emitting diode)

Intervention Type DEVICE

Placebo

810 nm GaAlAs diode laser device

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Gaziantep

OTHER

Sponsor Role lead

Responsible Party

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Merve Goymen

Head of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hasan Gundogar, PhD

Role: STUDY_CHAIR

Gaziantep University Periodontology Department

Seyithan Taysi, Prof

Role: STUDY_CHAIR

Gaziantep University Biochemistry Department

Central Contacts

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Merve Goymen, PhD

Role: CONTACT

+905054767651

Aslihan Karakas, MS

Role: CONTACT

Other Identifiers

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261

Identifier Type: -

Identifier Source: org_study_id

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