Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497244
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-24
Brief Title:
Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization a Split-mouth Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0017 x 0025 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 T2T4
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
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 0017 x 0025 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 T2T4
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None