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

NCT04175405 | Completed

• 1 other identifier: WroclawMU2212
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Malocclusion, Angle Class II

Keywords

ATP, biostimulation, micro-screw, Periotest, semiconductor laser

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pain level

  24 hours

• mini-implants loss

  60 days

Study Arms (2)

Right side of the maxilla

EXPERIMENTAL

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.

Procedure: Irradiation of implants with 635nm laser

Left side of the maxilla

NO INTERVENTION

Interventions

Irradiation of implants with 635nm laser PROCEDURE

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

Right side of the maxilla

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Private Dental Healtcare

Wschowa, Poland

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Lasers

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: March 6, 2019
• Primary Completion: June 2, 2019
• Study Completion: October 24, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)