Tooth LossNCT02513602
Osseointegrated Dental Implants in Kidney Transplanted Patients
An observational study of Tooth Loss and Disorder Related to Renal Transplantation, run by University of Trieste at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Disorder Related to Renal Transplantation
- What is being tested?
- Dental implant insertion
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital Company, "Ospadale Maggiore"
Trieste, TS, 34100
Federico Berton, DDS, 0403992254 ext. 0039, fberton@units.it
Gaetano Castronovo, MS, Msc, 0403992254 ext. 0039, gaetanoca@tiscali.it
About this study
Official title: Peri-Implant Bone Assessment in Transplanted Patients: A Case Control Study
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.
Read the 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
- 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
- Test group: periodontal evaluation with plaque index, bleeding on probing index and probing 1 month before operation.
- 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.
- 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.
- Test group: evaluation of the implant stability immediately after the insertion calculating the insertional torque value (ITV) with an implant motor.
- Test group: evaluation of the periimplant bone using an endoral periapical radiograph with Rinn device immediately after the operation.
- Test group: histomorphological examination of the bone core sample made by a trephine resulted from the implant site preparation
- Being tested
- Dental implant insertion
- Keywords
- implantology, kidney, renal disease, edentulism, tooth loss
- Medical subject headings
- Tooth Loss, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant insertionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Dental implant insertion | |
| CONTROL group (healthy patients) | Healthy patients, with an inserted mandibular implant, retrospectively enrolled with a preoperative cbct scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: seven days after cone beam computed tomography
Secondary outcomes (2)
Insertional torque value
Only for the test group the Insertional torque value will be assessed during surgery.
Measured: during implant placement
Histomorphometric analysis
Only for the test group the microscopic analysis will be performed on the specimen harvested during surgery (via trephine bur, preparing the implant site)
Measured: within 20 days after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2020 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. Roberto Di Lenarda, University of Trieste
- Investigators
- Roberto Di Lenarda, DDS, MSc, Study director, University of Trieste Medical School, Department of Odontology and Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513602
- Sponsor's protocol ID
- ITR
- Status last verified
- Nov 2016
- First submitted
- 20 Jul 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22251553Cassetta 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.
PubMed 23104660Zou 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.
PubMed 23876979
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Bone Assessment in Transplanted Patients: A Case Control Study
- ClinicalTrials.gov ID
- NCT02513602
- Acronym / sponsor ID
- ITR
- Keywords
- implantology, kidney, renal disease, edentulism, tooth loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2020 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Test group: periodontal evaluation with plaque index, bleeding on probing index and probing 1 month before operation.
- 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.
- 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.
- Test group: evaluation of the implant stability immediately after the insertion calculating the insertional torque value (ITV) with an implant motor.
- Test group: evaluation of the periimplant bone using an endoral periapical radiograph with Rinn device immediately after the operation.
- Test group: histomorphological examination of the bone core sample made by a trephine resulted from the implant site preparation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST group (kidney transplanted) | – | Procedure: Dental implant insertionKidney 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. |
| CONTROL group (healthy patients) | – | –Healthy patients, with an inserted mandibular implant, retrospectively enrolled with a preoperative cbct scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant insertionDental 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. | Procedure or surgery | TEST group (kidney transplanted) |
Primary outcome
Bone density measured in Grey Value
Time frame: seven days after cone beam computed tomography
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.
2 secondary outcomes
Insertional torque value
Time frame: during implant placement
Histomorphometric analysis
Time frame: within 20 days after implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 22251553Arisan 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.
- Background: PubMed 23104660Cassetta 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.
- Background: PubMed 23876979Zou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Di Lenarda, DDS, MSc study director
University of Trieste Medical School, Department of Odontology and Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Disorder Related to Renal Transplantation, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Berton, DDS (0403992254 ext. 0039, fberton@units.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density measured in Grey Value (time frame: seven days after cone beam computed tomography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02513602, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.