Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815589
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-04-04
Brief Title:
Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures A RCT
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Prosthetic Maintenance Assessment For Implant Fixed Complete Dentures With Implant Overdentures A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-04
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:
There are two types of complications in implant prosthesis biologic and prosthetic Biologic complications refer to disorders in implant function that disturb the supporting peri-implant tissues resulting in mucositis or periimplantitis in severe conditions the technical complications refer to subjecting the implant implant parts and or the superstructures to a damage such as screw loosening attachment wear fracture to part of the prosthesis or some of its teeth Prosthetic complications after the insertion of the final prosthesis may or may not lead to implant loss but lead to an increase demand for repair and maintenance
This study aimed to assess whether the telescopic overdenture as a removable prosthesis would necessitate maintaince at frequency similar to that with screw retained hybrid overdenture as a fixed prosthesis
This study aimed to assess whether the telescopic overdenture as a removable prosthesis would necessitate maintaince at frequency similar to that with screw retained hybrid overdenture as a fixed prosthesis
Detailed Description:
Sample size calculation This power analysis used frequency of implant complications as the primary outcome Based upon the results of Ragheb NA et al 2021 15the proportions of complications were 0407 and 0037 in the two groups respectively Using alpha α level of 5 and Beta β level of 20 ie power 80 the minimum estimated sample size was 19 implants per group Sample size was increased to twenty-two implants per group to compensate for a drop-out rate of 30 after two years Sample size calculation was performed using GPower Version 3192
Patients were recruited in the study from the Outpatient Clinic of the Prosthodontics Department Faculty of Dentistry Cairo University All of which were dissatisfied from their previous denture experience and seeking better retention to their mandibular denture Patients had received verbal and written information about the study procedures and a written informed consent was signed prior to participation
This study is a randomized clinical trial which was approved by the Ethics Committee of Scientific Research of Cairo University
In this study all participants had to install four interforaminal implants to receive either telescopic over-denture or screw retained denture
Before the prosthetic phase both groups were randomly assigned according to a computerized random allocation program where data of randomization were entered by the secretary of the department who neither participated in recruitment nor in examination procedures
Randomization and Allocation concealment was guaranteed as the randomization table was locked with the study coordinator who wasnt involved in any clinical intervention operator was informed about the treatment modality in a sealed enveloped delivered by the secretary of the department before impression procedures
Data collection was done by the study coordinator Blinding of the operator or data collector was not applicable due to the clear difference between the two prostheses but collected data was coded prior to sending to the statistician blinded statistician
A preoperative CBCT scan was taken for the participant s mandibular arch with a scan appliance The surgical steps were explained for all the participants and an informed consent was signed before surgery
Intra-foraminal root form tapered threaded dental implants Neo Biotech Co Ltd Seoul Korea were installed with 35 115 mm for the anterior and 3510 mm for posterior sites
Three months later the surgical stent was used to relocate the implants position for uncovering and the healing abutment was screwed with collar height 5mm to allow for proper gingival healing around the implants prior making the impression
The impression was made with an open tray splinted implant level impression technique According to randomization either a telescopic implant supported overdenture or a screw retained denture was fabricated for each case
During the follow -up period prosthetic complications were grouped and their frequency was documented according to the type of prosthesis Both prosthetic and biological aspects were included
Each complication was documented with stating the frequency of its occurrence any complication was managed and repaired
Patients were recruited in the study from the Outpatient Clinic of the Prosthodontics Department Faculty of Dentistry Cairo University All of which were dissatisfied from their previous denture experience and seeking better retention to their mandibular denture Patients had received verbal and written information about the study procedures and a written informed consent was signed prior to participation
This study is a randomized clinical trial which was approved by the Ethics Committee of Scientific Research of Cairo University
In this study all participants had to install four interforaminal implants to receive either telescopic over-denture or screw retained denture
Before the prosthetic phase both groups were randomly assigned according to a computerized random allocation program where data of randomization were entered by the secretary of the department who neither participated in recruitment nor in examination procedures
Randomization and Allocation concealment was guaranteed as the randomization table was locked with the study coordinator who wasnt involved in any clinical intervention operator was informed about the treatment modality in a sealed enveloped delivered by the secretary of the department before impression procedures
Data collection was done by the study coordinator Blinding of the operator or data collector was not applicable due to the clear difference between the two prostheses but collected data was coded prior to sending to the statistician blinded statistician
A preoperative CBCT scan was taken for the participant s mandibular arch with a scan appliance The surgical steps were explained for all the participants and an informed consent was signed before surgery
Intra-foraminal root form tapered threaded dental implants Neo Biotech Co Ltd Seoul Korea were installed with 35 115 mm for the anterior and 3510 mm for posterior sites
Three months later the surgical stent was used to relocate the implants position for uncovering and the healing abutment was screwed with collar height 5mm to allow for proper gingival healing around the implants prior making the impression
The impression was made with an open tray splinted implant level impression technique According to randomization either a telescopic implant supported overdenture or a screw retained denture was fabricated for each case
During the follow -up period prosthetic complications were grouped and their frequency was documented according to the type of prosthesis Both prosthetic and biological aspects were included
Each complication was documented with stating the frequency of its occurrence any complication was managed and repaired
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