Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04761445 |
Other study ID # |
FMD187 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 10, 2019 |
Est. completion date |
July 10, 2021 |
Study information
Verified date |
August 2021 |
Source |
Saint-Joseph University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 4.1 mm in diameter and length of 10 mm.
The second group (group 2) included patients receiving JD Octa implants of 4.3 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.