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

Malocclusion, Angle Class II Clinical Trial

Official title:

Low-level Laser Therapy With a 635nm Diode Laser Affects Orthodontic Mini-implants Stability. A Randomized Clinical Split-Mouth Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175405
• Other study ID #: WroclawMU2212
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: October 24, 2019

Study information

• Verified date: November 2019
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 24, 2019
• Est. primary completion date: June 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II

Intervention

Procedure:
• Irradiation of implants with 635nm laser
Irradiation of implants with 635nm laser with a dose of 10J

Locations

Country	Name	City	State
Poland	Private Dental Healtcare	Wschowa

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	mini-implants loss		60 days