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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04044989
Other study ID # 332
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2018
Est. completion date December 13, 2018

Study information

Verified date August 2019
Source University of Gaziantep
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 13, 2018
Est. primary completion date June 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Laser
Diode laser device was used for photobiomodulation
light-emitting diode (LED)
LED device was used for photobiomodulation
Placebo
Diode laser device was used for placebo effect

Locations

Country Name City State
Turkey Gaziantep University Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Root Resorption Crater volume measurement through study completion, an average of 4 weeks
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