Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511219
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Maxillary Segmental Distalization Using Digitally Printed Appliances
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Maxillary Segmental Distalization Using Infra Zygomatic Versus Palatal Digitally Printed Skeletal Anchored Appliances
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances
Detailed Description:
Ethical approval All selected patients will be informed about the aims and characteristics of the study the potential risks and benefits and the option of withdrawing from it whenever they desire Then all patients will sign the informed consent document All patients will be informed about the results after finishing All selected patients personal data and details will be held and handled confidentially and privately in the orthodontic department faculty of dentistry Mansoura university
Trial design
Patients will be randomly allocated into two groups as follow
1 First group Buccal segmental digitally printed maxillary distalizer infrazygomatic mini-implant IZC
2 Second group palatal segmental digitally printed maxillary distalizer
The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews
The distalizer will be composed of digitally printed metal shell which is bonded to the palatal surface of the whole posterior segment
Transpalatal arm will connect the two sides to avoid buccal tipping during distalization
The distalization will be done by placing chain elastics from the miniscrews to the hook present in the mesial aspect of the appliance
The palatal segmental distalizer will take anchorage from miniscrews placed in the anterior palate
The appliance will be bonded to the palatal surface of the posterior segment and containing two anterior and two posterior hooks
The distalization will be performed by using chain elastics between the anterior and posterior hooks
Force 300-350 gram per side which will be measured using force gauge
A follow-up session will be scheduled every 3weeks and the appliance will be removed in both groups after the patient reach a Class I relationship For each patient two lateral cephalograms will be obtained one preoperatively and another after completion of distalization
Trial design
Patients will be randomly allocated into two groups as follow
1 First group Buccal segmental digitally printed maxillary distalizer infrazygomatic mini-implant IZC
2 Second group palatal segmental digitally printed maxillary distalizer
The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews
The distalizer will be composed of digitally printed metal shell which is bonded to the palatal surface of the whole posterior segment
Transpalatal arm will connect the two sides to avoid buccal tipping during distalization
The distalization will be done by placing chain elastics from the miniscrews to the hook present in the mesial aspect of the appliance
The palatal segmental distalizer will take anchorage from miniscrews placed in the anterior palate
The appliance will be bonded to the palatal surface of the posterior segment and containing two anterior and two posterior hooks
The distalization will be performed by using chain elastics between the anterior and posterior hooks
Force 300-350 gram per side which will be measured using force gauge
A follow-up session will be scheduled every 3weeks and the appliance will be removed in both groups after the patient reach a Class I relationship For each patient two lateral cephalograms will be obtained one preoperatively and another after completion of distalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None