Photobiomodulation and Root Resorption

Orthodontic Appliance Complication Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044989
• Other study ID #: 332
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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