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Completed

NCT Number: NCT04044989

Photobiomodulation and Root Resorption

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.

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Key information

Conditions

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

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep University

Gaziantep, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

laser

Device

Diode laser device was used for photobiomodulation

light-emitting diode (LED)

Device

LED device was used for photobiomodulation

PLACEBO

Device

Diode laser device was used for placebo effect

Primary outcomes

  1. Root Resorption

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

    Crater volume measurement

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

Placebo-Controlled, Randomized, Double Blind Trial of Effect of Photobiomodulation Therapies On The Root Resorption Associated With Orthodontic Forces: A Pilot Study Using Micro Computed Tomography

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2019
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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