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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micro-osteoperforation | Experimental | Propel device (ABD) Micro-osteoperforations were performed in the keratinized tissue. Micro-osteoperforations were 1.5 mm in diameter and 3-7 mm in depth. |
|
| conventional treatment | Other | conventional fixed appliance treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro-osteoperforation | Device | Propel device (ABD) using for regional acceleratory phenomenon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Mandibular Teeth Alignment | tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month. | From the initiation of the treatment to the completion of alignment stage (approximately 6 months) |
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inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aslı Baysal, PhD | Izmir Katip Celebi University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Katip Celebi University | İzmirli | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37167078 | Derived | Faik Sahin M, Baysal A. The effect of micro-osteoperforation on the rate of tooth movement during the alignment stage in patients with mandibular crowding: a randomised controlled trial. Eur J Orthod. 2023 Sep 18;45(5):505-516. doi: 10.1093/ejo/cjad017. |
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Micro-Osteoperforation, Regional Acceleration Phenomenon, Orthodontic Alignment
Inclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Micro-osteoperforation | Propel device (ABD) micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel® is a single-use device specially produced for micro-osteoperforation. The device contains a 1.5 mm thick perforation tip. It has a depth adjustment of 3, 5 and 7 mm and the LED depth indicator gives a warning when the desired depth is reached. The device was removed from its sterile packaging and, after setting the desired depth, was gently placed on the gum and turned clockwise with a slight pressure. When the desired skin was reached, it was removed by turning counterclockwise with the LED indicator on. Micro-osteoperforations were performed directly and atraummatically in the keratinized gum from two or three points, 3 mm between canine canine, 5 mm between canine molar, and 7 mm deep in the posterior region and 1.5 mm in diameter in the alveolar bone. The procedure was applied at the beginning of the study in the areas of crowding and not repeated. |
| FG001 | Conventional Treatment | conventional fixed appliance treatment conventional fixed appliance treatment: conventional fixed appliance treatment. Leveling with 0.014 inch nickel titanium (Ni-Ti, American Orthodontics, Sheboygan, WI, USA) arc wire was started in patients in each group using traditional fixed orthodontic bracket. All patients were invited to the controls once a month and each session was measured and a plaster model was created until the leveling phase was completed. Depending on the leveling, 0.014 inch, 0.016 inch, 0.016x0.022 inch and finally 0.019x0.025 inch Ni-Ti (American Orthodontics, Sheboygan, WI, USA) wires were used respectively. In both groups, arc wires were connected to the slots with prefabricated steel wire ligatures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The patients who have little irregularity index is more than 5 mm in the mandibular arches
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| ID | Title | Description |
|---|---|---|
| BG000 | Micro-osteoperforation | Propel device (ABD) micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel device (ABD) micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel® is a single-use device specially produced for micro-osteoperforation. The device contains a 1.5 mm thick perforation tip. It has a depth adjustment of 3, 5 and 7 mm and the LED depth indicator gives a warning when the desired depth is reached. The device was removed from its sterile packaging and, after setting the desired depth, was gently placed on the gum and turned clockwise with a slight pressure. When the desired skin was reached, it was removed by turning counterclockwise with the LED indicator on. Micro-osteoperforations were performed directly and atraummatically in the keratinized gum from two or three points, 3 mm between canine canine, 5 mm between canine molar, and 7 mm deep in the posterior region and 1.5 mm in diameter in the alveolar bone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Mandibular Teeth Alignment | tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month. |
| Posted | Mean | Standard Deviation | millimeter (mm) | From the initiation of the treatment to the completion of alignment stage (approximately 6 months) |
|
1 year
No adverse effect were seen
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micro-osteoperforation | Propel device (ABD) micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr.dt.mücahid faik şahin | IzmirKCU | +902323254040 | m.faiksahin@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2016 | Aug 23, 2020 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2016 | Aug 23, 2020 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D003441 | Crowding |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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parallel assignment
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single outcome assessor
| conventional fixed appliance treatment | Other | conventional fixed appliance treatment |
|
| BG001 | Conventional Treatment | conventional fixed appliance treatment conventional fixed appliance treatment: conventional fixed appliance treatment conventional fixed appliance treatment conventional fixed appliance treatment: conventional fixed appliance treatment. Leveling with 0.014 inch nickel titanium (Ni-Ti, American Orthodontics, Sheboygan, WI, USA) arc wire was started in patients in each group using traditional fixed orthodontic bracket. All patients were invited to the controls once a month and each session was measured and a plaster model was created until the leveling phase was completed. Depending on the leveling, 0.014 inch, 0.016 inch, 0.016x0.022 inch and finally 0.019x0.025 inch Ni-Ti (American Orthodontics, Sheboygan, WI, USA) wires were used respectively. In both groups, arc wires were connected to the slots with prefabricated steel wire ligatures. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| little irregularity index | Irregularity index is used to calculate the amount of crowding in the dental arches and measured in millimeters. There is no need to compare the measure with a standart or a norm (and neither according to sex or race or age). Generally crowding lower than 4 mm is classified as mild, crowding between 4-8 mm called moderate and crowding above 8 mm classified as severe. | Mean | Standard Deviation | millimetres |
|
| OG001 | Conventional Treatment | conventional fixed appliance treatment conventional fixed appliance treatment: conventional fixed appliance treatment |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Conventional Treatment | conventional fixed appliance treatment conventional fixed appliance treatment: conventional fixed appliance treatment | 0 | 14 | 0 | 14 | 0 | 14 |
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