ImmunosuppressionNCT02547753
Dental Extractions Among Renal Transplant Recipients
An observational study of Immunosuppression, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The literature is rich in studies that explore the type and frequency of oral abnormalities in transplanted recipients, but it is scarce in studies that provide scientific evidence on the risk of complications after invasive interventions on those patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression
- How many people
- 106 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2015to 31 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: kidney transplanted individuals requiring extraction of erupetd teeth
Who may be able to join
- renal transplantation for more than 6 months
Who cannot join
- use of antibiotic in the previous month, use of bisphosphonate therapy, use of illicit drugs, chronic use of alcohol, having a dental emergency,having acute dental or periodontal infections, having a cognitive impairment.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Rubens Caliento
São Paulo, São Paulo, 05508000
University of São Paulo
São Paulo, 05508-000
About this study
Official title: Clinical Outcome of Dental Extractions Among Renal Transplant Recipients
The literature is rich in studies that explore the type and frequency of oral abnormalities in transplanted recipients, but it is scarce in studies that provide scientific evidence on the risk of complications after invasive interventions on those patients. Within this context, the aim of our study is to evaluate the post-exodontic socket healing in renal transplant recipients compared to a control group and see if some indicators in the population of transplanted people, such complete blood count, serum concentration of immunosuppressive drugs, can help to provide for the host response face a invasive procedures. Therefore, 45 kidney transplant recipients over six months and at least 45 healthy non immunosuppressed adults will be submitted to a maximum of 4 simple dental extractions, always by the same surgeon. Laboratory tests will be performed preoperatively and include: blood count and coagulation - for both groups - and urea, creatinine and serum levels of immunosuppressive drug - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7, 21, and 60 days. The presence, or absence, of post-operative complication and delayed, or not, socket healing will be the results of interest in this study and will be compared between the groups. The data will be evaluated by Pearson's chi-square, Fisher's exact test, Mann-Whitney test, student's T-test and binomial test.
Read the detailed description
Investigators did not found scientific evidences neither evidence-based research, which support the idea that stable kidney recipients have increased risk for delayed socket repair and wound healing after exodontia or that infections resulted by oral surgery are more common in these patients, despite the drug-induced immunosuppression which they use.
Since there is no scientific evidence about the increased risk of post-exodontic infection, not even about a disorder on the alveolar repair chronology, after exodontia performed in kidney recipients, the aim of our study will be prospectively observe kidney recipients who are undergoing dental extractions.
This prospective cohort study will involve 45 adult kidney recipients for at least 6 months, and 61 non-transplanted and healthy control adults, who need simple extraction of an erupted tooth.
All the patients must be evaluated in the preoperative phase through anamnesis (e.g. collecting data concerning on base diseases, personal history, presence of drug allergy, medications in use, habits and addictions), extra-oral and intra-oral physical examinations and laboratory tests.
Participants must sign the Inform and Clarified Consent Term to participate. Will be disqualified participants that: used antibiotics in the month preceding the extraction, made bisphosphonate therapy, user of illicit drugs, chronic alcoholics, who present with dental emergencies, acute dental or periodontal infections, and patients with cognitive impairment.
One week before the dental extraction will be collected 15ml of blood from participants of both group to perform complete blood count, coagulation tests, urea and creatinine measurements. The serum measurement of the immunosuppressed drug will be performed only in the individuals of study group.
Dental extractions, from one to three erupted teeth, will be performed by the same dentist, specialist in Oral and Maxillofacial Surgery, enabled by the Federal Council of Dentistry, on the ambulatory of CAPE (special care center) , under local anesthesia following the standards described by Peterson et al (2003). The local anesthetic used in all individuals will be prilocaine with epinephrine as vasoconstrictor. After the anesthetic blockade, incision and mucosal detachment, luxation with elevators and tooth removal with forceps will be performed. The surgical technique will be modified according the condition of the tooth on the socket; when necessary tooth sectioning and/or ostectomy will be performed. By the end, curettage of the socket, post-extraction alveolar compression to reduce the width of the same and simple suture with 4.0 silk thread will be carried out.
Each tooth characteristics and each surgery data will be recorded and will include: surgical duration (from the anesthesia to the suture), surgical technique variations, such the use of elevators, forceps, mucoperiosteal flaps, tooth sectioning and/or ostectomy and intraligamentary anesthesia, and number of anesthetics cartridges used.
After the surgery, the patient will press a gauze for 30 minutes in the extraction's region in order to control bleeding. It will be prescribed 750 mg of Acetominophen, up to 3 times a day, for 24 hours. In case of necessity of change in the postoperative therapeutic due to surgical technique variations, data will be recorded and included.
Clinical assessment of healing will be performed by a blinded examiner on 3, 7, 21 and 60 days after surgery. In these periods, the region will always be examined by the same examiner.
Radiographic evaluation will be done with standardized periapical radiographs, with individualized positioners, made in the immediately and 60 days postoperative, which bone density and alveolar crest remodeling will be evaluated by a blinded examiner.
With 21 days postoperative, the socket will be classified as: 1) without complication; or 2) with complications. According to Cheung et al (2001), the following situations will be considered as post-exodontics complications:
Acute alveolar infection (dry socket, fibrinolytic osteitis, alveolar osteitis) or surrounding tissue infection Acute alveolar inflammation.
In case of postoperatively infection, copious irrigation with sodium chloride solution (NaCl 0,9%) will be performed and will be prescribed amoxicilline 500 mg every 8 hours for 7 days and anti-inflammatory nimesulide 100 mg every 12 hours for 5 days. In case of allergy to penicillin, clindamycin will be prescribed at a dose of 300 mg every 8 hours for 7 days.
The second outcome of interest in this study will be observe the total alveolar epithelialization. According to the literature, at 3 days postoperative, the socket is filled with blood clot and fibrin; at 7 days, the socket is filled with granulation tissue; and from 21 days the surgical wound is fully epithelialized. Delayed epithelialization will be considered in case at on the day 21, the socket would not yet fully covered by epithelialized mucosa.
Finally, the third point will be the bone deposition in the socket, at 60 days postoperative.
All data will be transferred to an Excel spreadsheet and analyzed descriptively and associated with each other. Complications will be compared between the two groups. In addition, in the study group, researchers will investigate the occurrence of complications associated with transplantation time, immunosuppressive dose, and presence of comorbidity, such as diabetes.
Exact Fisher's test or Fisher's exact test will be applied, Mann-Whitney's test or Student's T-test and binomial test using the R software, version 2.15.3 (R Development Core Team, 2012). The significance level will be set at 5%. Adjustments to modifying factors such as smoking and presence of diabetes will be analyzed by logistic regression.
- Conditions
- Immunosuppression
- Keywords
- Tooth extraction, Antibiotic prophylaxis, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transplanted group | patients who are kidney receptors for at least 6 months and need tooth extraction | |
| Control group | healthy patients who need tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
alveolar healing will be classified in complicated or non-complicated, based on the conditions and symptoms of soft tissue healing
Measured: 21 days
Secondary outcomes (1)
Delayed alveolar healing
alveolar healing will be classified in normal or delayed healing based on the chronology of alveolar and soft tissue healing
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion1 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo, Hospital do Rim e Hipertensão, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marina Helena Cury Gallottini, University of Sao Paulo
- Investigators
- Marina Gallottini, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547753
- Sponsor's protocol ID
- CAAE: 45413015.0.0000.0075
- Status last verified
- Nov 2018
- First submitted
- 9 Sep 2015
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All the data will be available after the end of study
Publications
Guggenheimer J, Eghtesad B, Stock DJ. Dental management of the (solid) organ transplant patient. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Apr;95(4):383-9. doi: 10.1067/moe.2003.150.
PubMed 12686921Brown RS, McIntosh CL, Cotca CC, Glascoe AL. Dental management of a kidney transplant patient. Dent Today. 2012 Jul;31(7):74-6; quiz 78-9. No abstract available.
PubMed 22891597Byron RJ Jr, Osborne PD. Dental management of liver transplant patients. Gen Dent. 2005 Jan-Feb;53(1):66-9; quiz 70-2.
PubMed 15779227Cheung LK, Chow LK, Tsang MH, Tung LK. An evaluation of complications following dental extractions using either sterile or clean gloves. Int J Oral Maxillofac Surg. 2001 Dec;30(6):550-4. doi: 10.1054/ijom.2000.0128.
PubMed 11829239Cohen D, Galbraith C. General health management and long-term care of the renal transplant recipient. Am J Kidney Dis. 2001 Dec;38(6 Suppl 6):S10-24. doi: 10.1053/ajkd.2001.28922.
PubMed 11729002Georgakopoulou EA, Achtari MD, Afentoulide N. Dental management of patients before and after renal transplantation. Stomatologija. 2011;13(4):107-12.
PubMed 22362336Guggenheimer J, Mayher D, Eghtesad B. A survey of dental care protocols among US organ transplant centers. Clin Transplant. 2005 Feb;19(1):15-8. doi: 10.1111/j.1399-0012.2005.00251.x.
PubMed 15659128Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. doi: 10.1056/NEJM200003023420901.
PubMed 10699159Lockhart PB, Brennan MT, Fox PC, Norton HJ, Jernigan DB, Strausbaugh LJ. Decision-making on the use of antimicrobial prophylaxis for dental procedures: a survey of infectious disease consultants and review. Clin Infect Dis. 2002 Jun 15;34(12):1621-6. doi: 10.1086/340619. Epub 2002 May 23.
PubMed 12032898Lockhart PB, Loven B, Brennan MT, Fox PC. The evidence base for the efficacy of antibiotic prophylaxis in dental practice. J Am Dent Assoc. 2007 Apr;138(4):458-74; quiz 534-5, 437. doi: 10.14219/jada.archive.2007.0198.
PubMed 17403736Weinberg MA, Segelnick SL, Kay LB, Nair V. Medical and dental standardization for solid organ transplant recipients. N Y State Dent J. 2013 Nov;79(6):35-40.
PubMed 24600763Ziebolz D, Hrasky V, Goralczyk A, Hornecker E, Obed A, Mausberg RF. Dental care and oral health in solid organ transplant recipients: a single center cross-sectional study and survey of German transplant centers. Transpl Int. 2011 Dec;24(12):1179-88. doi: 10.1111/j.1432-2277.2011.01325.x. Epub 2011 Sep 8.
PubMed 21902726Spolidorio LC, Spolidorio DM, Massucato EM, Neppelenbroek KH, Campanha NH, Sanches MH. Oral health in renal transplant recipients administered cyclosporin A or tacrolimus. Oral Dis. 2006 May;12(3):309-14. doi: 10.1111/j.1601-0825.2005.01200.x.
PubMed 16700742Caliento R, Sa Fernandes K, Andrade NS, de Santana Sarmento DJ, Pontello Cristelli M, L Ortega K, Gallottini M. Extractions in kidney transplant recipients: A prospective observational pilot study. J Am Dent Assoc. 2022 Mar;153(3):233-240. doi: 10.1016/j.adaj.2021.08.004. Epub 2021 Nov 20.
PubMed 34794682
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Dental Extractions Among Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT02547753
- Acronym / sponsor ID
- CAAE: 45413015.0.0000.0075
- Conditions
- Immunosuppression
- Keywords
- Tooth extraction, Antibiotic prophylaxis, Postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of São Paulo, Hospital do Rim e Hipertensão, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2015
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Sep 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 literature is rich in studies that explore the type and frequency of oral abnormalities in transplanted recipients, but it is scarce in studies that provide scientific evidence on the risk of complications after invasive interventions on those patients. Within this context, the aim of our study is to evaluate the post-exodontic socket healing in renal transplant recipients compared to a control group and see if some indicators in the population of transplanted people, such complete blood count, serum concentration of immunosuppressive drugs, can help to provide for the host response face a invasive procedures. Therefore, 45 kidney transplant recipients over six months and at least 45 healthy non immunosuppressed adults will be submitted to a maximum of 4 simple dental extractions, always by the same surgeon. Laboratory tests will be performed preoperatively and include: blood count and coagulation - for both groups - and urea, creatinine and serum levels of immunosuppressive drug - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7, 21, and 60 days. The presence, or absence, of post-operative complication and delayed, or not, socket healing will be the results of interest in this study and will be compared between the groups. The data will be evaluated by Pearson's chi-square, Fisher's exact test, Mann-Whitney test, student's T-test and binomial test.
Detailed description
Investigators did not found scientific evidences neither evidence-based research, which support the idea that stable kidney recipients have increased risk for delayed socket repair and wound healing after exodontia or that infections resulted by oral surgery are more common in these patients, despite the drug-induced immunosuppression which they use.
Since there is no scientific evidence about the increased risk of post-exodontic infection, not even about a disorder on the alveolar repair chronology, after exodontia performed in kidney recipients, the aim of our study will be prospectively observe kidney recipients who are undergoing dental extractions.
This prospective cohort study will involve 45 adult kidney recipients for at least 6 months, and 61 non-transplanted and healthy control adults, who need simple extraction of an erupted tooth.
All the patients must be evaluated in the preoperative phase through anamnesis (e.g. collecting data concerning on base diseases, personal history, presence of drug allergy, medications in use, habits and addictions), extra-oral and intra-oral physical examinations and laboratory tests.
Participants must sign the Inform and Clarified Consent Term to participate. Will be disqualified participants that: used antibiotics in the month preceding the extraction, made bisphosphonate therapy, user of illicit drugs, chronic alcoholics, who present with dental emergencies, acute dental or periodontal infections, and patients with cognitive impairment.
One week before the dental extraction will be collected 15ml of blood from participants of both group to perform complete blood count, coagulation tests, urea and creatinine measurements. The serum measurement of the immunosuppressed drug will be performed only in the individuals of study group.
Dental extractions, from one to three erupted teeth, will be performed by the same dentist, specialist in Oral and Maxillofacial Surgery, enabled by the Federal Council of Dentistry, on the ambulatory of CAPE (special care center) , under local anesthesia following the standards described by Peterson et al (2003). The local anesthetic used in all individuals will be prilocaine with epinephrine as vasoconstrictor. After the anesthetic blockade, incision and mucosal detachment, luxation with elevators and tooth removal with forceps will be performed. The surgical technique will be modified according the condition of the tooth on the socket; when necessary tooth sectioning and/or ostectomy will be performed. By the end, curettage of the socket, post-extraction alveolar compression to reduce the width of the same and simple suture with 4.0 silk thread will be carried out.
Each tooth characteristics and each surgery data will be recorded and will include: surgical duration (from the anesthesia to the suture), surgical technique variations, such the use of elevators, forceps, mucoperiosteal flaps, tooth sectioning and/or ostectomy and intraligamentary anesthesia, and number of anesthetics cartridges used.
After the surgery, the patient will press a gauze for 30 minutes in the extraction's region in order to control bleeding. It will be prescribed 750 mg of Acetominophen, up to 3 times a day, for 24 hours. In case of necessity of change in the postoperative therapeutic due to surgical technique variations, data will be recorded and included.
Clinical assessment of healing will be performed by a blinded examiner on 3, 7, 21 and 60 days after surgery. In these periods, the region will always be examined by the same examiner.
Radiographic evaluation will be done with standardized periapical radiographs, with individualized positioners, made in the immediately and 60 days postoperative, which bone density and alveolar crest remodeling will be evaluated by a blinded examiner.
With 21 days postoperative, the socket will be classified as: 1) without complication; or 2) with complications. According to Cheung et al (2001), the following situations will be considered as post-exodontics complications:
Acute alveolar infection (dry socket, fibrinolytic osteitis, alveolar osteitis) or surrounding tissue infection Acute alveolar inflammation.
In case of postoperatively infection, copious irrigation with sodium chloride solution (NaCl 0,9%) will be performed and will be prescribed amoxicilline 500 mg every 8 hours for 7 days and anti-inflammatory nimesulide 100 mg every 12 hours for 5 days. In case of allergy to penicillin, clindamycin will be prescribed at a dose of 300 mg every 8 hours for 7 days.
The second outcome of interest in this study will be observe the total alveolar epithelialization. According to the literature, at 3 days postoperative, the socket is filled with blood clot and fibrin; at 7 days, the socket is filled with granulation tissue; and from 21 days the surgical wound is fully epithelialized. Delayed epithelialization will be considered in case at on the day 21, the socket would not yet fully covered by epithelialized mucosa.
Finally, the third point will be the bone deposition in the socket, at 60 days postoperative.
All data will be transferred to an Excel spreadsheet and analyzed descriptively and associated with each other. Complications will be compared between the two groups. In addition, in the study group, researchers will investigate the occurrence of complications associated with transplantation time, immunosuppressive dose, and presence of comorbidity, such as diabetes.
Exact Fisher's test or Fisher's exact test will be applied, Mann-Whitney's test or Student's T-test and binomial test using the R software, version 2.15.3 (R Development Core Team, 2012). The significance level will be set at 5%. Adjustments to modifying factors such as smoking and presence of diabetes will be analyzed by logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplanted group | – | –patients who are kidney receptors for at least 6 months and need tooth extraction |
| Control group | – | –healthy patients who need tooth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- kidney transplanted individuals requiring extraction of erupetd teeth
Key inclusion criteria (1 listed)
- renal transplantation for more than 6 months
Key exclusion criteria (1 listed)
- use of antibiotic in the previous month, use of bisphosphonate therapy, use of illicit drugs, chronic use of alcohol, having a dental emergency,having acute dental or periodontal infections, having a cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication
Time frame: 21 days
alveolar healing will be classified in complicated or non-complicated, based on the conditions and symptoms of soft tissue healing
1 secondary outcome
Delayed alveolar healing
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Background: PubMed 12686921Guggenheimer J, Eghtesad B, Stock DJ. Dental management of the (solid) organ transplant patient. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Apr;95(4):383-9. doi: 10.1067/moe.2003.150.
- Background: PubMed 22891597Brown RS, McIntosh CL, Cotca CC, Glascoe AL. Dental management of a kidney transplant patient. Dent Today. 2012 Jul;31(7):74-6; quiz 78-9. No abstract available.
- Background: PubMed 15779227Byron RJ Jr, Osborne PD. Dental management of liver transplant patients. Gen Dent. 2005 Jan-Feb;53(1):66-9; quiz 70-2.
- Background: PubMed 11829239Cheung LK, Chow LK, Tsang MH, Tung LK. An evaluation of complications following dental extractions using either sterile or clean gloves. Int J Oral Maxillofac Surg. 2001 Dec;30(6):550-4. doi: 10.1054/ijom.2000.0128.
- Background: PubMed 11729002Cohen D, Galbraith C. General health management and long-term care of the renal transplant recipient. Am J Kidney Dis. 2001 Dec;38(6 Suppl 6):S10-24. doi: 10.1053/ajkd.2001.28922.
- Background: PubMed 22362336Georgakopoulou EA, Achtari MD, Afentoulide N. Dental management of patients before and after renal transplantation. Stomatologija. 2011;13(4):107-12.
- Background: PubMed 15659128Guggenheimer J, Mayher D, Eghtesad B. A survey of dental care protocols among US organ transplant centers. Clin Transplant. 2005 Feb;19(1):15-8. doi: 10.1111/j.1399-0012.2005.00251.x.
- Background: PubMed 10699159Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh MJ, Stablein D. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000 Mar 2;342(9):605-12. doi: 10.1056/NEJM200003023420901.
- Background: PubMed 12032898Lockhart PB, Brennan MT, Fox PC, Norton HJ, Jernigan DB, Strausbaugh LJ. Decision-making on the use of antimicrobial prophylaxis for dental procedures: a survey of infectious disease consultants and review. Clin Infect Dis. 2002 Jun 15;34(12):1621-6. doi: 10.1086/340619. Epub 2002 May 23.
- Background: PubMed 17403736Lockhart PB, Loven B, Brennan MT, Fox PC. The evidence base for the efficacy of antibiotic prophylaxis in dental practice. J Am Dent Assoc. 2007 Apr;138(4):458-74; quiz 534-5, 437. doi: 10.14219/jada.archive.2007.0198.
- Background: PubMed 24600763Weinberg MA, Segelnick SL, Kay LB, Nair V. Medical and dental standardization for solid organ transplant recipients. N Y State Dent J. 2013 Nov;79(6):35-40.
- Background: PubMed 21902726Ziebolz D, Hrasky V, Goralczyk A, Hornecker E, Obed A, Mausberg RF. Dental care and oral health in solid organ transplant recipients: a single center cross-sectional study and survey of German transplant centers. Transpl Int. 2011 Dec;24(12):1179-88. doi: 10.1111/j.1432-2277.2011.01325.x. Epub 2011 Sep 8.
- Individual participant dataSharing planned: Yes. All the data will be available after the end of study
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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.
Marina Gallottini principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression, run by University of Sao Paulo at 2 sites in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: 21 days). 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 NCT02547753, which also lists 14 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 28 Nov 2018.