Microosteoperforations
Conditions
Brief summary
The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.
Detailed description
The design of this randomized controlled clinical trial is a parallel group, two arms trial * Preparatory phase * Self-drilling mini-screws will be placed buccally between upper 2nd premolar and 1st molar bilaterally in the last NiTi wire insertion visit. * After the completion of levelling and alignment phase an intra oral scan will be made for the upper arch and a rigid stainless-steel retraction arch wire 0.017 x 0.025 will be inserted. * The patient will then be referred to the radiology center and a pre-retraction cone beam computed tomography (CBCT) image will be taken for the maxillary arch (T0). * Experimental phase * Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months. * Molar distalization will started immediately after performing the MOPs using sliding jig distalizer. * The force will be applied to the mini-screw with the sliding jig mechanics on average 300 gm using Nickel-titanium closing coil springs. * Before leaving the clinic, the patient will be asked to: * Use chlorhexidine three times per day for 3 days after MOP applications. * avoid using pain killers (except Panadol when needed). * fill in a Numeric pain rating scale. * Follow up phase * Follow up visits will be scheduled every 4 weeks for reactivation coil spring and check TADs stability. * An intra oral scan for the upper arch will made every visit. * The study time will be continued for 6 months (T1, T2, T3, T4, T5, T6). * The same technique of MOP will be repeated after 2 and 4 months of follow up (T2,T4). * After 6 months of follow up, the final dental model will made, and the patient will be referred to the same radiology center to acquire the post-distalization CBCT.
Interventions
PROCEDUREmicro osteo-perforation
the patient will receive miniscrew micro osteo-perforation in one side every month with molar distalization and the other side the distalization without micro osteo-perforation
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The first assessor will perform the digital models & CBCT measurements blindly for each patient. The second assessor will perform the same measurements blindly to calculate the inter-observer error
Intervention model description
Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult patients 2. Skeletal Class I or mild Class II relationship 3. Dental class II bilaterally (non-extraction cases) 4. Full permanent dentition including 2nd maxillary molars 5. Good oral hygiene 6. Medically free
Exclusion criteria
1. Systemic diseases that may interfere with the treatment 2. Use of any medications that might have affected the biology of tooth movement 3. unilateral Class II molar relationship 4. extreme skeletal Class II relationship (ANB \>7°) 5. periodontal disease or alveolar bone loss 6. Patients with dental anomalies in maxillary 1st molar
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of molar distalization | 6 months | Incremental rate of molar distalization every month by intra oral scan superimposition |
| total molar distalization distance by mm between T6 and T0 | 6 months | Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0 | 6 months | comparing the pre- & post- distalization CBCT and measure the linear change in the 1st molar vertical position by mm between T6 and T0 |
| The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0 | 6 months | comparing the pre- & post- distalization CBCT and measure the angular change in the 1st molar long axis tipping by degree between T6 and T0 |
| Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale | 1 week | using Numeric Pain Rating Scale filled by the patient with minimum value is zero and maximum value 10 (the higher score mean worse outcome) |
| The effect of MOPs on 1st molar root resorption level by mm between T6 and T0 | 6 months | comparing the pre- & post- distalization CBCT and measure the amount of root resorption of 1st molar roots by mm between T6 and T0 |
| The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0 | 6 months | comparing the pre- & post- distalization digital models and CBCT and measure the angular change in the 1st molar long axis rotation by degree between T6 and T0 |
Countries
Egypt
Contacts
Primary ContactMohamed Elsayed, PhD
Outcome results
None listed