NCT02513602

Osseointegrated Dental Implants in Kidney Transplanted Patients

Peri-Implant Bone Assessment in Transplanted Patients: A Case Control Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 26 (estimated)
• Sponsor: University of Trieste · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tooth Loss
• Disorder Related to Renal Transplantation

Interventions

Type	Name	Description
PROCEDURE	Dental implant insertion	Dental implant insertion will be carry out in the mandible of the patients enrolled, through a surgical template in order to repeat the same position of the simulating implant insertion. After a trephine bur passage, the final two or three twist-drills will be used to realize the implant socket. After implant positioning, a cover screw will be tightened and the mucosa sutured above.

Timeline

• Start date: 2014-05-01
• Primary completion: 2020-05-01
• Completion: 2022-08-01
• First posted: 2015-07-31
• Last updated: 2016-11-02

Locations

1 site across 1 country: Italy