Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-04-18 @ 4:53 PM
Study NCT ID:
NCT03243695
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2017-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Abutment Angulation on Implant Failure in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides: RCT
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Implant Failure When Using Angled Versus Straight Abutments in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides:A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-06
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:
patients with fractured teeth in the esthetic area requiring immediate restoration will be recruited to the study. Immediate implants will be placed and patients will be restored either with straight or angled abutments. Implant failure will be measured.
Detailed Description:
A: General operative procedures:
The study will be explained in details to the eligible participants with all possible alternative treatment options and possible risk.
If a patient accepts the treatment, informed consent will be signed. Standard extra oral and intraoral examination will be carried out. Diagnostic charts will be filled including medical and past dental history.
The patient will choose a sealed envelope to determine the allocation group. Preliminary impressions will be taken. The tooth to be extracted will be trimmed from the cast and an ideal wax up will be done.
A hard vacuum stent 2 mm thickness will be constructed over the cast with the wax up for fabrication of the temporary crown later.
The patient will be imaged a cone beam computerized topography (CBCT). The acquired DICOM image will be assessed on blue sky software ®. All the cases must have adequate buccolingual bone, if not the patient will be excluded from the study.
The co-supervisor (MW) will inform the principle investigator (HF) with the allocation group.
The principle investigator (HF) will plan the case. The implants will be planned apical to socket depth to engage apical bone for better primary stability. Final implant position 3 dimensionally will be according to allocation group to allow for placement of either straight or angled abutment.
The guide will be exported from the software and printed.
Intra operative procedures:
Patients will administrate a prophylactic antibiotic 3 days ahead the surgery. The procedure will be carried out under local anesthesia under sterile conditions.
The remaining tooth will be extracted atraumatically using periotome for better bone preservation.
After tooth extraction, the socket will be curettaged and irrigated with copious saline till fresh bleeding from the socket is observed.
Surgical guide will be placed and checked for stability and drilling will be performed following instructions.
Before implant insertion, the prepared osteotomy will be lavaged thoroughly to remove any drill debris from the socket.
The implant will be placed and the insertion torque will be checked using manual torque wrench. Implants with insertion torque less than 35Ncm will not be loaded and will be excluded from the study.
Periapical radiographs will be taken to ensure proper seating of the implant. The abutment, whether straight or angled according to the allocation group, will be attached to the implant fixture.
The vacuum stent will be used to perform the temporary crown using autopolymerizing resin. The crown will be checked to be out of occlusion in centric and eccentric occlusion to avoid any premature contact and subsequent overloading. Then the crown will be cemented and excess cement will be removed using dental floss.
The patient will be called for follow up after 1 week for the first 3 weeks then at 1 month and 3 months.
The study will be explained in details to the eligible participants with all possible alternative treatment options and possible risk.
If a patient accepts the treatment, informed consent will be signed. Standard extra oral and intraoral examination will be carried out. Diagnostic charts will be filled including medical and past dental history.
The patient will choose a sealed envelope to determine the allocation group. Preliminary impressions will be taken. The tooth to be extracted will be trimmed from the cast and an ideal wax up will be done.
A hard vacuum stent 2 mm thickness will be constructed over the cast with the wax up for fabrication of the temporary crown later.
The patient will be imaged a cone beam computerized topography (CBCT). The acquired DICOM image will be assessed on blue sky software ®. All the cases must have adequate buccolingual bone, if not the patient will be excluded from the study.
The co-supervisor (MW) will inform the principle investigator (HF) with the allocation group.
The principle investigator (HF) will plan the case. The implants will be planned apical to socket depth to engage apical bone for better primary stability. Final implant position 3 dimensionally will be according to allocation group to allow for placement of either straight or angled abutment.
The guide will be exported from the software and printed.
Intra operative procedures:
Patients will administrate a prophylactic antibiotic 3 days ahead the surgery. The procedure will be carried out under local anesthesia under sterile conditions.
The remaining tooth will be extracted atraumatically using periotome for better bone preservation.
After tooth extraction, the socket will be curettaged and irrigated with copious saline till fresh bleeding from the socket is observed.
Surgical guide will be placed and checked for stability and drilling will be performed following instructions.
Before implant insertion, the prepared osteotomy will be lavaged thoroughly to remove any drill debris from the socket.
The implant will be placed and the insertion torque will be checked using manual torque wrench. Implants with insertion torque less than 35Ncm will not be loaded and will be excluded from the study.
Periapical radiographs will be taken to ensure proper seating of the implant. The abutment, whether straight or angled according to the allocation group, will be attached to the implant fixture.
The vacuum stent will be used to perform the temporary crown using autopolymerizing resin. The crown will be checked to be out of occlusion in centric and eccentric occlusion to avoid any premature contact and subsequent overloading. Then the crown will be cemented and excess cement will be removed using dental floss.
The patient will be called for follow up after 1 week for the first 3 weeks then at 1 month and 3 months.
Study Oversight
Has Oversight DMC:
True
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?: