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.
Verified date | November 2019 |
Source | Wroclaw Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Private Dental Healtcare | Wschowa |
Lead Sponsor | Collaborator |
---|---|
Wroclaw Medical University |
Poland,
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 |
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