Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-08 @ 7:42 AM
Study NCT ID:
NCT02513602
Status:
UNKNOWN
Last Update Posted:
2016-11-02
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osseointegrated Dental Implants in Kidney Transplanted Patients
Sponsor:
University of Trieste
Organization:
Study Overview
Official Title:
Peri-Implant Bone Assessment in Transplanted Patients: A Case Control Study
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
RECRUITING
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 evaluation of the bone, using several techniques and on several aspects will be the purpose to study the possible impact of the kidney transplant (and, extensively, the pre-transplant dialysis, the organ replacement and the immunosuppressive therapy) could have on the bone metabolism and on the density of the bone where the implants are placed. The assessment on the bone density only in a retrospectively selected population that underwent the same surgical procedure will help the comparison of the data to get a satisfactory conclusion. The evaluation of other clinical and instrumental parameters in the test group makes the kidney-transplant patients bone quality clear, and will consequently demonstrate if implants are a feasible therapy for these patients.
Detailed Description:
The primary purpose of this study is the evaluation of the effects of the kidney transplant on the periimplant bone density by the comparison with the density of healthy patients. The secondary purpose is obtaining clinical, histological and radiographic data to evaluate the effect of systemic conditions and its rebound on the insertion of fixtures.
Evaluation criteria
1. Control group: evaluation of the periimplant bone density (1 mm) next to the implant virtually planned using the CT editing software on the cone beam CT acquired in a retrospective sample of patients already treated with the insertion of a fixture in the molar or premolar edentulous site
2. Test group: periodontal evaluation with plaque index, bleeding on probing index and probing 1 month before operation.
3. Test group: evaluation of periimplant bone density (1 mm) in the fixture virtual-projected zone (the implant will be inserted there) with the CT acquisition and editing software.
4. Test group: evaluation of the implant stability after their insertion (primary stability) using the Resonance Frequence Analysis. ISQ (Implant Stability Quotient) value is expressed in 4 numbers (mesial, distal, buccal, lingual), average values of three measures acquired in each side.
5. Test group: evaluation of the implant stability immediately after the insertion calculating the insertional torque value (ITV) with an implant motor.
6. Test group: evaluation of the periimplant bone using an endoral periapical radiograph with Rinn device immediately after the operation.
7. Test group: histomorphological examination of the bone core sample made by a trephine resulted from the implant site preparation
Evaluation criteria
1. Control group: evaluation of the periimplant bone density (1 mm) next to the implant virtually planned using the CT editing software on the cone beam CT acquired in a retrospective sample of patients already treated with the insertion of a fixture in the molar or premolar edentulous site
2. Test group: periodontal evaluation with plaque index, bleeding on probing index and probing 1 month before operation.
3. Test group: evaluation of periimplant bone density (1 mm) in the fixture virtual-projected zone (the implant will be inserted there) with the CT acquisition and editing software.
4. Test group: evaluation of the implant stability after their insertion (primary stability) using the Resonance Frequence Analysis. ISQ (Implant Stability Quotient) value is expressed in 4 numbers (mesial, distal, buccal, lingual), average values of three measures acquired in each side.
5. Test group: evaluation of the implant stability immediately after the insertion calculating the insertional torque value (ITV) with an implant motor.
6. Test group: evaluation of the periimplant bone using an endoral periapical radiograph with Rinn device immediately after the operation.
7. Test group: histomorphological examination of the bone core sample made by a trephine resulted from the implant site preparation
Study Oversight
Has Oversight DMC:
True
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?: