Osseointegrated Dental Implants in Kidney Transplanted Patients
NCT ID: NCT02513602
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
26 participants
OBSERVATIONAL
2014-05-31
2022-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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TEST group (kidney transplanted)
Kidney transplanted patients, passed through dialysis phase presenting a mandibular edentulism. It will be scheduled one or two dental implants to be inserted in mandible.
This group will be subjected to a dental implant insertion 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.
CONTROL group (healthy patients)
Healthy patients, with an inserted mandibular implant, retrospectively enrolled with a preoperative cbct scan.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Good systemic compensation of the kidney transplant (≤ ASA American Society of Anesthesiologists score 3) with at least 1 year of previous hemodialysis or peritoneal dialysis and in actual immunosuppressive therapy
* Be older than 18 years
* The patient must be able to understand the meaning of the study and accept to undergo periodical follow-up controls.
* The patient must be able to understand and practice all the oral hygiene procedures demanded by the experimenter
* Signature of the informed consent form
and for control
* Diagnosis: single or partial mandibular molar-premolar edentulism that requires up to 2 fixtures
* Having a pre-operatory cone beam CT available
* Age older than 18 years
* Signature of the authorization to use and process personal details at the acceptance of every sort of treatment in the Company Hospital of Trieste.
Exclusion Criteria
* Be less than 18 years old
* Smoking more than 10 cigarettes/day
* Plaque index more than 25
* Bleeding on probe index more than 25
* Clear allergy or intolerance against the products used in the study
* Patients that require reconstructive bone surgery before the fixtures placement (gbr and bone grafting)
and for control group
* Patients that require reconstructive bone surgery before the fixtures placement (gbr and bone grafting)
* Pathologies and pharmacological therapies that interfere with bone (for instance osteoporosis, osteomalacia, malnutrition, Paget's disease, corticosteroid therapy, bisphosphonate therapy, head and neck radiotherapy)
18 Years
ALL
No
Sponsors
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University of Trieste
OTHER
Responsible Party
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prof. Roberto Di Lenarda
Professor
Principal Investigators
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Roberto Di Lenarda, DDS, MSc
Role: STUDY_DIRECTOR
University of Trieste Medical School, Department of Odontology and Stomatology
Locations
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University Hospital Company, "Ospadale Maggiore"
Trieste, TS, Italy
Countries
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Central Contacts
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Facility Contacts
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Federico Berton, DDS
Role: primary
Gaetano Castronovo, MS, Msc
Role: backup
References
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Arisan V, Karabuda ZC, Avsever H, Ozdemir T. Conventional multi-slice computed tomography (CT) and cone-beam CT (CBCT) for computer-assisted implant placement. Part I: relationship of radiographic gray density and implant stability. Clin Implant Dent Relat Res. 2013 Dec;15(6):893-906. doi: 10.1111/j.1708-8208.2011.00436.x. Epub 2012 Jan 17.
Cassetta M, Stefanelli LV, Di Carlo S, Pompa G, Barbato E. The accuracy of CBCT in measuring jaws bone density. Eur Rev Med Pharmacol Sci. 2012 Oct;16(10):1425-9.
Zou H, Zhao X, Sun N, Zhang S, Sato T, Yu H, Chen Q, Weber HP, Dard M, Yuan Q, Lanske B. Effect of chronic kidney disease on the healing of titanium implants. Bone. 2013 Oct;56(2):410-5. doi: 10.1016/j.bone.2013.07.014. Epub 2013 Jul 19.
Other Identifiers
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ITR
Identifier Type: -
Identifier Source: org_study_id