Osseointegrated Dental Implants in Kidney Transplanted Patients

NCT02513602 | Unknown DMC

• 1 other identifier: ITR
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss; Disorder Related to Renal Transplantation

Keywords

implantology; kidney; renal disease; edentulism; tooth loss

Outcome Measures

Primary Outcomes (1)

• Bone density measured in Grey Value

  bone density will be assessed on the cone beam CT scans with the virtual implant positioning before surgery (for the test group) and postoperatively (retrospectively assessed) for the control group. Grey Value will be assessed in the area of 1 mm around the shape of the implants.

  seven days after cone beam computed tomography

Secondary Outcomes (2)

• Insertional torque value

  during implant placement

• Histomorphometric analysis

  within 20 days after implant placement

Study Arms (2)

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.

Procedure: Dental implant insertion

CONTROL group (healthy patients)

Healthy patients, with an inserted mandibular implant, retrospectively enrolled with a preoperative cbct scan.

Interventions

Dental implant insertion PROCEDURE

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.

TEST group (kidney transplanted)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The minimal number of the participants of this study is 26 per group: this results from the measure of a 0,8 effect size. If the effect size is less than 1 (minimal value), it represents the situation where the medium difference of standard deviations of the variable "bone density" is equivalent to the difference of the value between the two groups of the study. Subject of test group will be enrolled an a kidney transplanted patients, while Subjects of control group will be enrolled retrospectively in healthy patients

You may qualify if:

• Diagnosis: single or partial mandibular molar-premolar edentulism that requires up to 2 fixtures
• 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.

You may not qualify if:

• Post extraction implant (before 3 months from the extraction)
• 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)

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

University Hospital Company, "Ospadale Maggiore"

Trieste, TS, 34100, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 22251553 BACKGROUND

• 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.

  PMID: 23104660 BACKGROUND

• 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.

  PMID: 23876979 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

bone specimen harvested during implant site preparation in order to obtain usefull samples for hystomorphometrical analysis

MeSH Terms

Conditions

Tooth Loss; Kidney Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Roberto Di Lenarda, DDS, MSc

  University of Trieste Medical School, Department of Odontology and Stomatology

  STUDY DIRECTOR

Central Study Contacts

Federico Berton, DDS

CONTACT

0403992254; fberton@units.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 31, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2022
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

IT (1)