Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser

Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser: Primary and Secondary Stability. A Randomized Clinical Split-Mouth Trial.

The study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class II
• Intervention / Treatment: Procedure: Irradiation of implants with 635nm laser

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wschowa, Poland
    • Private Dental Healtcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
• the patients were treated first time using fixed orthodontic appliance;
• no systemic diseases;
• were not using anti-inflammatory drugs;

Exclusion Criteria:

• had used antibiotics in the previous 24 months;
• smokers;
• had history of radiotherapy,
• taking bisphosphonate medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right side of the maxilla; the right side of the maxilla	Procedure: Irradiation of implants with 635nm laser; Irradiation of implants with 635nm laser
No Intervention: Left side of the maxilla; left side of the maxilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stability of orthodontic mini-implants	The mini-implants stability was estimated employing a Periotest device (Medzintechnik Gulden e K, Modautal, Germany). The Periotest measurement system includes the sound formed from contact between an object and a metallic tapping bar in a handpiece, which is electromagnetically driven and electronically verified. The Periotest response detection is analyzed through a fast Fourier transform (FFT) algorithm. Simply put, the Periotest answer to tapping is estimated by an accelerometer and then analyzed. The signal generated by tapping is then transformed to a value called the Periotest value (PTV), which depends on the damping characteristics of the peri-implant tissue. [27] The Periotest Test values (PTVs) are based on a numerical scale ranging from -8 to +50, defined by mathematical computation. The lower Periotest values indicate higher implant stability and thereupon the higher absorption effect of the target objects.	60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Immediately after the mini-implants placement, each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10). The maximum pain level was measured at both sides of the maxilla during the first day after the treatment. The NRS-11 scale consists of a conscious, subjective assessment of the pain experienced; therefore, it is used in the case of patients over ten years old. A rating of 0 signifies no pain, 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain.	24 hours
mini-implants loss		60 days

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2019
• Primary Completion (Actual): May 12, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ATP, biostimulation, micro-screw, Periotest, semiconductor laser
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: WroclawMU6354J

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No