Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II
• Interventions: Procedure: Irradiation of implants with 635nm laser

• Registration Number: NCT04175405
• Lead Sponsor: Wroclaw Medical University

Brief Summary

The study aimed to clinically estimate an influence of a 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 20 patients (13 women and 7 men; age: 32.5 ± 6.1 years).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Primary Completion: 2019-06-02
• Study Completion: 2019-10-24
• Status Verified: 2019-11
• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Last Update Submitted: 2019-11-21
• Study First Posted: 2019-11-25
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Arm && Interventions

Group	Intervention	Description
Right side of the maxilla	Irradiation of implants with 635nm laser	The 635-nm laser parameters; dose: 10J per point (20J/cm2), time: 100 sec per point, 2 points (irradiation on a buccal, and a palatal side of the alveolus/implant), the total energy per session 20J.

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.

Secondary Outcome Measures

Name	Time	Method
Pain level	24 hours	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.
mini-implants loss	60 days

Trial Locations

Locations (1)

Private Dental Healtcare; 🇵🇱 Wschowa, Poland