Malocclusion, Angle Class II
Conditions
Keywords
ATP, biostimulation, micro-screw, Periotest, semiconductor laser
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).
Interventions
Irradiation of implants with 635nm laser with a dose of 10J
Sponsors
Wroclaw Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. \[27\] 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 24 hours | 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. |
| mini-implants loss | 60 days | — |
Countries
Poland
Outcome results
None listed