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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2019-10-24

Brief Summary

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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).

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Detailed Description

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Conditions

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Malocclusion, Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Right side of the maxilla

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.

Group Type EXPERIMENTAL

Irradiation of implants with 635nm laser

Intervention Type PROCEDURE

Irradiation of implants with 635nm laser with a dose of 10J

Left side of the maxilla

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Irradiation of implants with 635nm laser

Irradiation of implants with 635nm laser with a dose of 10J

Intervention Type PROCEDURE

Eligibility Criteria

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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;