Clinical trial NCT03652454: The Evaluation Of The Efficiency Of Micro-osteoperforation
Official title: Efficiency Of Micro-osteoperforation During Alignment Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowding of Teeth
Keywords: regional acceleratory phenomenon
micro-osteoperforation
orthodontic alignment
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

Brief summary: Prolonged orthodontic treatment increases the risc of caries, periodontal problems and root resorption. Many different techniques were developed to shorten the treatment time. The aim of this study was to evaluate the effectiveness of micro-osteoperforations (MOP) performed in the alignment stage.

Twenty eight patients with mandibular arch discrepancy will be included in this research. After the patients are informed about the study they will be requested to sign the consent form.. At the beginning of the treatment routine orthodontic records (photographs, dental models and radiographs) will be taken and the gingival pocket measurements will be made.

The twenty eight patients will be randomly divided in two groups. In the first group, 3 or 4 micro-osteoperforations will be made in the parts of the gingiva nearby the discrepancy by perforating the keratinized or non-keratinized mucosa and reaching the alveolar bone under local anesthesia. In the further appointments the traditional aligning procedures will be used and controls will be made every 7-9 days. In the other group 20 patients will be treated in the traditional way and controls will be made each month. Every patient will be requested to answer questions related to treatment comfort and other problems like pain within the first week after each activations. The records will be repeated after the leveling phase. Tooth movement rate will be calculated according to the measurements made on dental casts. Measurements related to cephalometrics and gingival thickness will be evaluated. The results of two groups will be compared in terms of tooth movement rate, gingival thickness, pain and patient comfort.

Detailed description: Twenty eight patients who have crowding in mandibular arch will be included in the study.

At the beginning of the study, routine orthodontic records and gingival measurements will be taken.All the records will be repeated after alignment stage.

Clinical periodontal parameters including plaque index, gingival index, pocket depth and bleeding were measured with Williams periodontal scaler (Hu Friedy®, Chicago, IL, USA).

Gingival thickness will be recorded with a ultrasonic device (Pirop® Ultrasonic Biometer A- Scan, Echo-Son, Krancowa, Poland) Irregularity index will be calculated for each patient using dental casts. After bracket placement; twenty eight patients will be randomly allocated to treatment and control groups (fourteen patients in each group) While micro-osteoperforations will be applied to treatment group, the control group will receive no additional treatment.

Each patient will be asked to fulfill a questionnaire to evaluate patient satisfaction and ease of operation.

The data was analyzed statistically and the level of statistical significance was determined as p ≤ .05.

Eligibility criteria: inclusion Criteria:

1. Existence of all permanent teeth (except molars 2 and 3)
2. Subjects aged 30 and below
3. Confusion of less than 8 mm according to model analysis of the upper and lower sieves
4. Gingival and periodontal indices of less than 1
5. Good oral hygiene

Exclusion Criteria:

1. Congenitally missing tooth
2. Severe skeletal malocclusion
3. Systemic disease affecting tooth movement
4. Active periodontal disease
5. Smoking
6. Radiographically detected bone loss
7. Gingival pocket depth greater than 4 mm
8. Previous surgical periodontal or orthodontic treatment

Primary outcomes:
measure: Rate of Mandibular Teeth Alignment
timeFrame: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: İzmirli
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
affiliation: Izmir Katip Celebi University
name: Aslı Baysal, PhD
role: STUDY_DIRECTOR
References: