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CompletedNCT04044989Updated Aug 5, 2019

Photobiomodulation and Root Resorption

An interventional study of Laser and light-emitting diode (LED) in Orthodontic Pathological Resorption of External Root, Orthodontic Appliance Complication and Orthodontic Tooth Movement, sponsored by University of Gaziantep. Completed at 1 site in Turkey. Open to participants aged 15 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by University of Gaziantep · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
15 Years to 17 Years
Sex
All
01

Study summary

Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the ............. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.

02

Conditions studied

  • Orthodontic Pathological Resorption of External Root
  • Orthodontic Appliance Complication
  • Orthodontic Tooth Movement

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Keywords

  • photobiomodulation
  • laser
  • LED
  • resorption
  • micro-CT
03

Who can participate

Ages eligible
15 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No history of orthodontic treatment
  • No systemic disease or craniofacial anomaly
  • No dental trauma and tooth with root resorption
  • Having good oral hygiene
  • No periodontal disease (no more than 3mm pocket)
  • No restored or endodontically untreated upper right 1st premolar teeth
  • Having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment

Exclusion criteria

Exclusion Criteria:

  • Problems in patient compliance
  • Inadequate oral hygiene
  • Development of any medical problem making orthodontic treatment contraindicated during the study period
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Root resorption (total)

    The resorption cavities on the root surface were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

    Device: Laser · Device: light-emitting diode (LED) · Device: Placebo

  • Experimental
    Root resorption (local)

    The resorption cavities on the root surface (palatal, buccal, distal and mesial root surfaces) were determined and the volumes of the cavities were measured in CTAn software (micro-CT).

    Device: Laser · Device: light-emitting diode (LED) · Device: Placebo

Interventions

  • DeviceLaser

    Diode laser device was used for photobiomodulation

  • Devicelight-emitting diode (LED)

    LED device was used for photobiomodulation

  • DevicePlacebo

    Diode laser device was used for placebo effect

05

What researchers measure

Primary outcomes

  1. Root Resorption

    Crater volume measurement

    Time frame: through study completion, an average of 4 weeks

06

Study locations

1 site
  • Gaziantep University
    Gaziantep, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04044989
Lead sponsor
University of Gaziantep
Responsible party
Merve Goymen (Asisst. Prof., University of Gaziantep) — Principal investigator
First posted
Aug 5, 2019
Start date
Jan 10, 2018
Primary completion
Jun 5, 2018
Completion
Dec 13, 2018
Last update
Aug 5, 2019

Study contacts

Aysegul Gulec, PhD
principal investigator · Gaziantep University Orthodontics Department
Merve Goymen, PhD
study chair · Gaziantep University Orthodontics Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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