Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514391
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture A Study of Peri Implant Soft Tissue Health and Marginal Bone Loss
Status:
COMPLETED
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:
this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture The evaluation will be done clinically and radiographically as following
Marginal bone loss
Soft tissue changes around the implants
Marginal bone loss
Soft tissue changes around the implants
Detailed Description:
Six patients of age ranging from 40 to 60years mean 50 years were selected for this study from the out patients clinic Prosthodontics department Faculty of Dentistry Mansoura University
I Preparation of the patient for implant placement
1 A cone beam CT was done for each patient to determine the bone height and the adequate sites for the placement of four interforaminal implants
2 Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement
II Surgical phase
1 Surgical stent was used to guide in implant placement All implants were placed according to the flapless protocol under local anesthesia
2 All patients received four dental implants located anterior to the mental foramen in canine and premolar position
III Prosthetic phase
1 The necks of the placed implants were bent up to 15 degree to ensure parallelism
2 Intraoral final impression was done by intraoral scanner to be used for digital designing of the milled bar and the final prosthesis
3 bar design was milled in PMMA resin material and tried over implants then resin bar try-in was invested and casted in co-cr alloy
4 Final bar was inserted intra-orally after finishing and polishing
5 The four implant bar assembly was then loaded by the prefabricated acrylic denture according to Browaeys H et al 2014 Access holes were made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol
6 The occlusion was adjusted and the patients were instructed to go on soft diet for the first 48 hours until final impressions and delivery of milled bar overdenture were done
IV Evaluation
Probing depth was measured for each implant using plastic probe and radiographic evaluation of the peri-implant marginal bone loss by using cone beam CT started for the patients from the delivery of final prosthesis T0 and continue for 6 months T6 and 12 month T12 from insertion
I Preparation of the patient for implant placement
1 A cone beam CT was done for each patient to determine the bone height and the adequate sites for the placement of four interforaminal implants
2 Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement
II Surgical phase
1 Surgical stent was used to guide in implant placement All implants were placed according to the flapless protocol under local anesthesia
2 All patients received four dental implants located anterior to the mental foramen in canine and premolar position
III Prosthetic phase
1 The necks of the placed implants were bent up to 15 degree to ensure parallelism
2 Intraoral final impression was done by intraoral scanner to be used for digital designing of the milled bar and the final prosthesis
3 bar design was milled in PMMA resin material and tried over implants then resin bar try-in was invested and casted in co-cr alloy
4 Final bar was inserted intra-orally after finishing and polishing
5 The four implant bar assembly was then loaded by the prefabricated acrylic denture according to Browaeys H et al 2014 Access holes were made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol
6 The occlusion was adjusted and the patients were instructed to go on soft diet for the first 48 hours until final impressions and delivery of milled bar overdenture were done
IV Evaluation
Probing depth was measured for each implant using plastic probe and radiographic evaluation of the peri-implant marginal bone loss by using cone beam CT started for the patients from the delivery of final prosthesis T0 and continue for 6 months T6 and 12 month T12 from insertion
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