Malocclusion, Angle Class II
Conditions
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.
Interventions
PROCEDUREIrradiation of implants with 808nm laser
Irradiation of implants with 808nm laser
Sponsors
Wroclaw Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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. 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 (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. |
| mini-implants loss | 60 days | Mini-implants survival rate was assessed during 60 days observation period. |
Countries
Poland
Outcome results
None listed