Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04942808 |
Other study ID # |
FMDA9/21 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 1, 2021 |
Est. completion date |
July 29, 2022 |
Study information
Verified date |
June 2021 |
Source |
Saint-Joseph University |
Contact |
Layal Bou Semaan, DDS |
Phone |
+96178898880 |
Email |
layal.bs[@]live.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal is to evaluate, after 5 to 8 years, the marginal bone loss around tissue-level
implants and bone-level implants in patients who have not followed the maintenance program.
Medical records of patients who have been implanted for at least 5 to 8 years and who have
been lost during this period are collected from three private clinics in Beirut,Lebanon and
the Saint Joseph University Health Center in Beirut,Lebanon.
On an individual sheet, the patient as well as the implants data will be noted. Patients will
be called for reevaluation after 5-8 years. After signing the informed consent, the
measurements by a PCP-15 probe of the plaque index (FMPS) and the bleeding index (FMBS) as
well as the height of the keratinized tissue are indicated on the sheet. If the smoking
status has changed, this will be mentioned too.
The marginal bone loss will be measured on the X-rays taken immediately after the implant
placement, after 1 year of loading and then at the reevaluation session.
Description:
On the individual sheet for each patient, the data concerning the name, age, sex, general
condition, smoking status, periodontal status , the number of follow-up sessions and the
plaque index as well as bleeding on probing (if noted in the file before placing the
implants) will be recorded.
Then, the data concerning the implant such as the site (maxilla or mandibular), the type of
implant, the length, the diameter, the surface, sealed or screwed, presence of a cantilever,
hiatus or over-contour, a one or two surgical time, the date of placement and the number of
years of operation will also be noted on the form.
Patients will be called for reassessment appointments after 5-8 years. After signing the
informed consent, the measurements by a PCP-15 periodontal probe of the plaque index (FMPS),
bleeding on probing (FMBS) as well as the height and thickness of the keratinized mucosa are
indicated on the sheet. The smoking status will also be updated and indicated.
Implants will be classified into one of these groups:
1. Patients with tissue implants (TL).
2. Patients with bone level implants with internal connection (BL, Internal hex).
3. Patients with bone level implants with external connection (BL, External hex).
X-rays taken after insertion, after 1 year of loading and after 5-8 years will be collected
and analyzed on the DBSWIN software. Mesial and distal bone loss after implant placement and
after 5 to 8 years will be measured on retro-alveolar radiographs with calibration and
recorded on the patient file. The total bone loss will then be calculated.
The radiographic measurement technique is as follows. The platform of the mesial and distal
implant (MIS: Mesial Implant Shoulder and DIS: Distal Implant Shoulder) will be defined and a
line (A) connecting the two is drawn. Another line (B) tangential to the apex of the implant
and parallel to A is also drawn. The bisecting line at A and B is therefore produced and
measured to assess the distorted implant length (DIL: Distorted Implant Length). Bone level
(BL) measurements will be recorded from the implant platform (MIS-DIS) to the most coronary
bone-to-implant contact (BIC) on the mesial and distal sides of each implant. The length of
the implant will be used as an actual measurement to calibrate the other measurements.