Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761445
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2020-12-16
Brief Title:
Comparison Between Two Different Tissue-Level Implant Systems A Prospective Clinical Study
Sponsor:
Saint-Joseph University
Organization:
Saint-Joseph University
Study Overview
Official Title:
Comparison Between Two Different Tissue-Level Implant Systems A Prospective Clinical Study
Status:
COMPLETED
Status Verified Date:
2021-08
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 objective of this prospective study is to compare clinically and radiographically two different tissue-level implants in partially edentulous patients in the posterior area of the maxilla and mandible The primary objective of the study was to track the crestal bone level changes around the two implant systems Secondary objectives were implant stability as well as initial soft tissue thickness which were evaluated throughout this study
Detailed Description:
The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible The primary outcome is the change in the interproximal crestal bone level
Patients in this study were recruited from the general population attending the department of Periodontology at the Saint-Joseph University Adult patients males and females in need of implant rehabilitation for partial edentulism in the posterior maxilla and mandible have been selected to take part in this study Following initial screening procedures each patient underwent a site-specific intraoral and radiographic examination Cone Beam Computed Tomography analysis and periapical radiographs in order to make sure that the inclusion criteria were satisfied Patients presenting with bone width of less than 6 mm or more than 9 mm were immediately excluded from the study The day of the surgery each implantation site was given a number depending on the tooth missing Then using a random team generator software each site was randomly assigned to one of the two groups based on the implant system used
The first group group 1 consisted of patients receiving Straumann Standard Plus SP implants of 41 mm in diameter and length of 10 mm
The second group group 2 included patients receiving JD Octa implants of 43 mm in diameter and 10 mm in length
Participants were blinded as to the assignment in the first or second group The implant placement procedures were planned based on clinical and radiographic evaluation
The following parameters were monitored for each case
Crestal bone level changes CBL
Primary and secondary implant stability
Initial soft tissue thickness
After a healing time of 3 months Patients were recalled 6 and 12 months after prosthetic treatment At each visit the restorations were evaluated for mobility oral hygiene peri-implant soft tissue conditions and patient satisfaction Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes CBL changes were defined as the difference between two consecutive CBL measurements Secondary implant stability was evaluated Impressions were taken at the implant level Abutments were fixed on the implants with titanium screws
In order to reduce the risk of bias in the study all the implant-supported crowns were screw retained However in only one case and due to prosthetic considerations two implant-supported crowns were cemented using a temporary cement In this case the restorations were thoroughly checked for excessive cement
Final restorations were delivered within 2 weeks of referral Finally standardized radiographs were taken to ensure abutment seating and check for residual cement in the case of cemented crowns
Patients were recalled 6 and 12 months after prosthetic treatment At each visit the restorations were evaluated for mobility oral hygiene peri-implant soft tissue conditions and patient satisfaction Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes As described previously CBL changes were defined as the difference between two consecutive CBL measurements
Patients in this study were recruited from the general population attending the department of Periodontology at the Saint-Joseph University Adult patients males and females in need of implant rehabilitation for partial edentulism in the posterior maxilla and mandible have been selected to take part in this study Following initial screening procedures each patient underwent a site-specific intraoral and radiographic examination Cone Beam Computed Tomography analysis and periapical radiographs in order to make sure that the inclusion criteria were satisfied Patients presenting with bone width of less than 6 mm or more than 9 mm were immediately excluded from the study The day of the surgery each implantation site was given a number depending on the tooth missing Then using a random team generator software each site was randomly assigned to one of the two groups based on the implant system used
The first group group 1 consisted of patients receiving Straumann Standard Plus SP implants of 41 mm in diameter and length of 10 mm
The second group group 2 included patients receiving JD Octa implants of 43 mm in diameter and 10 mm in length
Participants were blinded as to the assignment in the first or second group The implant placement procedures were planned based on clinical and radiographic evaluation
The following parameters were monitored for each case
Crestal bone level changes CBL
Primary and secondary implant stability
Initial soft tissue thickness
After a healing time of 3 months Patients were recalled 6 and 12 months after prosthetic treatment At each visit the restorations were evaluated for mobility oral hygiene peri-implant soft tissue conditions and patient satisfaction Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes CBL changes were defined as the difference between two consecutive CBL measurements Secondary implant stability was evaluated Impressions were taken at the implant level Abutments were fixed on the implants with titanium screws
In order to reduce the risk of bias in the study all the implant-supported crowns were screw retained However in only one case and due to prosthetic considerations two implant-supported crowns were cemented using a temporary cement In this case the restorations were thoroughly checked for excessive cement
Final restorations were delivered within 2 weeks of referral Finally standardized radiographs were taken to ensure abutment seating and check for residual cement in the case of cemented crowns
Patients were recalled 6 and 12 months after prosthetic treatment At each visit the restorations were evaluated for mobility oral hygiene peri-implant soft tissue conditions and patient satisfaction Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes As described previously CBL changes were defined as the difference between two consecutive CBL measurements
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?:
False
Is an FDA AA801 Violation?:
None