Photobiomodulation and Root Resorption

NCT04044989 | Completed

• 1 other identifier: 332
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

photobiomodulation; laser; LED; resorption; micro-CT

Outcome Measures

Primary Outcomes (1)

• Root Resorption

  Crater volume measurement

  through study completion, an average of 4 weeks

Study Arms (2)

Root resorption (total)

EXPERIMENTAL

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

Root resorption (local)

EXPERIMENTAL

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

Laser DEVICE

Diode laser device was used for photobiomodulation

Root resorption (local); Root resorption (total)

light-emitting diode (LED) DEVICE

LED device was used for photobiomodulation

Root resorption (local); Root resorption (total)

Placebo DEVICE

Diode laser device was used for placebo effect

Root resorption (local); Root resorption (total)

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Aysegul Gulec, PhD

  Gaziantep University Orthodontics Department

  PRINCIPAL INVESTIGATOR

• Merve Goymen, PhD

  Gaziantep University Orthodontics Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst. Prof.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 5, 2019
• Study Start: January 10, 2018
• Primary Completion: June 5, 2018
• Study Completion: December 13, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)