Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II
• Interventions: Procedure: Irradiation of implants with 808nm laser

• Registration Number: NCT04276402
• Lead Sponsor: Wroclaw Medical University

Brief Summary

The study aimed to evaluate the influence of a 635nm diode laser on the stability of orthodontic mini-implants in vitro, as well as mini-implants failure rate (mini-implant loss) and patients pain level after the treatment. A randomized clinical split-mouth trial was concluded with 22 subjects (14 women, 8 men), 44 orthodontic mini-implants with a diameter 1.4mm and length of 10mm. Mini-implants were placed between teeth 3 and 4; and 13 and 14 (Universal Numbering System), in the area of the attached gingiva, 2 mm below mucogingival junction.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-05
• Primary Completion: 2019-10-12
• Study Completion: 2019-11-02
• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Study First Posted: 2020-02-19
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 808nm laser	-

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. 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
mini-implants loss	60 days	Mini-implants survival rate was assessed during 60 days observation period.
Pain level (NRS scale)	24 hours	Each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10) immediately following placement of mini-implants. 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.; 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.

Trial Locations

Locations (1)

Private Dental Healtcare; 🇵🇱 Kościan, Poland