Dental Extractions Among Renal Transplant Recipients

NCT02547753 | Completed DMC

• 1 other identifier: CAAE: 45413015.0.0000.0075
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Immunosuppression

Keywords

Tooth extraction; Antibiotic prophylaxis; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Complication

  alveolar healing will be classified in complicated or non-complicated, based on the conditions and symptoms of soft tissue healing

  21 days

Secondary Outcomes (1)

• Delayed alveolar healing

  60 days

Study Arms (2)

Transplanted group

patients who are kidney receptors for at least 6 months and need tooth extraction

Control group

healthy patients who need tooth extraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

kidney transplanted individuals requiring extraction of erupetd teeth

You may qualify if:

• renal transplantation for more than 6 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Federal University of São Paulo: collaborator
• Hospital do Rim e Hipertensão: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Rubens Caliento

São Paulo, São Paulo, 05508000, Brazil

Location

University of São Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (14)

• 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.

  PMID: 12686921 BACKGROUND

• Brown 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.

  PMID: 22891597 BACKGROUND

• Byron RJ Jr, Osborne PD. Dental management of liver transplant patients. Gen Dent. 2005 Jan-Feb;53(1):66-9; quiz 70-2.

  PMID: 15779227 BACKGROUND

• Cheung 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.

  PMID: 11829239 BACKGROUND

• Cohen 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.

  PMID: 11729002 BACKGROUND

• Georgakopoulou EA, Achtari MD, Afentoulide N. Dental management of patients before and after renal transplantation. Stomatologija. 2011;13(4):107-12.

  PMID: 22362336 BACKGROUND

• Guggenheimer 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.

  PMID: 15659128 BACKGROUND

• Hariharan 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.

  PMID: 10699159 BACKGROUND

• Lockhart 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.

  PMID: 12032898 BACKGROUND

• Lockhart 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.

  PMID: 17403736 BACKGROUND

• Weinberg 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.

  PMID: 24600763 BACKGROUND

• Ziebolz 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.

  PMID: 21902726 BACKGROUND

• Spolidorio 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.

  PMID: 16700742 BACKGROUND

• Caliento 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.

  PMID: 34794682 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood and saliva - laboratorial tests

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Gallottini

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Prof Oral Pathology

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: August 31, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after the end of the study
• Access Criteria: General public

Locations

BR (2)