Photobiomodulation and Root Resorption

NCT ID: NCT04044989

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2018-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Laser

Intervention Type: DEVICE

Diode laser device was used for photobiomodulation

light-emitting diode (LED)

Intervention Type: DEVICE

LED device was used for photobiomodulation

Placebo

Intervention Type: DEVICE

Diode laser device was used for placebo effect

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).

Group Type: EXPERIMENTAL

Laser

Intervention Type: DEVICE

Diode laser device was used for photobiomodulation

light-emitting diode (LED)

Intervention Type: DEVICE

LED device was used for photobiomodulation

Placebo

Intervention Type: DEVICE

Diode laser device was used for placebo effect

Interventions

Laser

Diode laser device was used for photobiomodulation

Intervention Type: DEVICE

light-emitting diode (LED)

LED device was used for photobiomodulation

Intervention Type: DEVICE

Placebo

Diode laser device was used for placebo effect

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Gaziantep

OTHER

Sponsor Role: lead

Responsible Party

Merve Goymen

Asisst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aysegul Gulec, PhD

Role: PRINCIPAL_INVESTIGATOR

Gaziantep University Orthodontics Department

Merve Goymen, PhD

Role: STUDY_CHAIR

Gaziantep University Orthodontics Department

Locations

Gaziantep University

Gaziantep, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

332

Identifier Type: -

Identifier Source: org_study_id