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

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II

• Registration Number: NCT04170127
• Lead Sponsor: Wroclaw Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-02
• Primary Completion: 2019-05-12
• Study Completion: 2019-08-02
• Status Verified: 2019-11
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-17
• Last Update Submitted: 2019-11-17
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
stability of orthodontic mini-implants	60 days	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.

Trial Locations

Locations (1)

Private Dental Healtcare; 🇵🇱 Wschowa, Poland