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

NCT04170127 | Completed DMC

• 1 other identifier: WroclawMU6354J
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Other Outcomes (2)

• Pain level

  24 hours

• mini-implants loss

  60 days

Study Arms (2)

Right side of the maxilla

EXPERIMENTAL

the right side of the maxilla

Procedure: Irradiation of implants with 635nm laser

Left side of the maxilla

NO INTERVENTION

left side of the maxilla

Interventions

Irradiation of implants with 635nm laser PROCEDURE

Irradiation of implants with 635nm laser

Right side of the maxilla

Eligibility Criteria

• Gender Eligibility Details: 10 women and 5 man
• 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 14, 2019
• First Posted: November 20, 2019
• Study Start: February 2, 2019
• Primary Completion: May 12, 2019
• Study Completion: August 2, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

PL (1)