Crowding of Teeth
Conditions
Keywords
regional acceleratory phenomenon, micro-osteoperforation, orthodontic alignment
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.
Interventions
DEVICEmicro-osteoperforation
Propel device (ABD) using for regional acceleratory phenomenon
OTHERconventional fixed appliance treatment
conventional fixed appliance treatment
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single outcome assessor
Intervention model description
parallel assignment
Eligibility
Sex/Gender
ALL
Age
12 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Mandibular Teeth Alignment | From the initiation of the treatment to the completion of alignment stage (approximately 6 months) | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Micro-Osteoperforation, Regional Acceleration Phenomenon, Orthodontic Alignment Inclusion Criteria: * All permanent teeth have been worn (except 3rd molar) * More than 5 mm perforation compared to LII * Gingival and periodontal indices less than 1 * Good hygiene
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Micro-osteoperforation | Conventional Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 12 Participants | 23 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| little irregularity index | 9.99 millimetres STANDARD_DEVIATION 2.63 | 8.87 millimetres STANDARD_DEVIATION 1.5 | 9.42 millimetres STANDARD_DEVIATION 2.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment Turkey | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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.
Time frame: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)
Population: * All permanent teeth have been erupted (except the 3rd molars)~* Presence of more than 5 mm crowding in the lower arc according to Little irregularity index~* Gingival and periodontal indices less than 1~* Good oral hygiene~* Patient and / or guardian volunteering to participate in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micro-osteoperforation | Rate of Mandibular Teeth Alignment | second months | 2.08 millimeter (mm) | Standard Deviation 0.91 |
| Micro-osteoperforation | Rate of Mandibular Teeth Alignment | fourth months | 0.84 millimeter (mm) | Standard Deviation 0.95 |
| Micro-osteoperforation | Rate of Mandibular Teeth Alignment | third months | 1.94 millimeter (mm) | Standard Deviation 0.99 |
| Micro-osteoperforation | Rate of Mandibular Teeth Alignment | fifth months | 0.34 millimeter (mm) | Standard Deviation 0.57 |
| Micro-osteoperforation | Rate of Mandibular Teeth Alignment | first month | 4.27 millimeter (mm) | Standard Deviation 1.75 |
| Conventional Treatment | Rate of Mandibular Teeth Alignment | fifth months | 0.93 millimeter (mm) | Standard Deviation 0.7 |
| Conventional Treatment | Rate of Mandibular Teeth Alignment | first month | 2.82 millimeter (mm) | Standard Deviation 0.87 |
| Conventional Treatment | Rate of Mandibular Teeth Alignment | second months | 2.31 millimeter (mm) | Standard Deviation 1.29 |
| Conventional Treatment | Rate of Mandibular Teeth Alignment | third months | 1.54 millimeter (mm) | Standard Deviation 0.65 |
| Conventional Treatment | Rate of Mandibular Teeth Alignment | fourth months | 0.89 millimeter (mm) | Standard Deviation 0.49 |