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Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series

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ClinicalTrials.gov Identifier: NCT03454490
Recruitment Status : Unknown
Verified March 2018 by Simon Jean, Hopital de l'Enfant-Jesus.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Simon Jean, Hopital de l'Enfant-Jesus

Study Description
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Brief Summary:
Gingival recession is defined as the apical migration of the gingival margin from the amelocemental junction. This condition may be associated with symptoms such as tooth hypersensitivity, root decay, and cosmetic complaints from patients. Many treatments have been used to treat gingival recession and the gold standard is the autogenous connective tissue gingival graft because of its predictability. This type of gingival graft is performed by harvesting connective tissue from patients' hard palate. Periodontists and general dentists frequently perform these gingival grafts. Occasionally, some patients develop postoperative complications that need to be addressed in an hospital setting. An uncommon but concerning complication of an autogenous connective tissue gingival graft is a donor site pseudoaneurysm of the greater palatine artery. No description of this complication following a gingival graft has been identified in the current literature. One case report mentioned that pseudoaneurysm of the greater palatine artery looks like a pulsatile nodule associated or not with pain on palpation. From the experience of the investigators, patients may consult an hospital setting having a complaint of major oral bleeding. Local hemostatic agents can palliate this type of bleeding, but angiographic embolization is often required. Several cases were treated in the investigators' hospital. Thus, the investigators believe it is relevant to share this experience with the scientific community. The primary objective of this case series is to inform dental professionals of the existence and the management of postoperative pseudoaneurysm of the greater palatine artery following autogenous gingival graft. The secondary objective is to find potential solutions to minimize the incidence of this morbid complication.

Condition or disease Intervention/treatment
Pseudoaneurysm Procedure: Postoperative pseudoaneurysm of the greater palatine artery

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018
Groups and Cohorts
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Intervention Details:
  • Procedure: Postoperative pseudoaneurysm of the greater palatine artery
    Patients had an autogenous connective tissue gingival graft.

Outcome Measures
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Primary Outcome Measures :
  1. Postoperative oral bleeding [ Time Frame: One month following autogenous connective tissue gingival graft ]
    Complication following autogenous connective tissue gingival graft


Secondary Outcome Measures :
  1. Use of local hemostatic agents [ Time Frame: Six months ]
    Palliative method before definitive care

  2. Secondary effects following angiographic intervention [ Time Frame: Six months ]
    Postoperative infection, bone or gum necrosis, extrusion of embolization material, loss of tooth, tooth devitalization following angiographic intervention

  3. Number of followups required [ Time Frame: Six months ]
    Secondary effects following angiographic intervention


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients having a diagnostic of pseudoaneurysm of the greater palatine artery who had an autogenous connective tissue gingival graft
Criteria

Inclusion Criteria:

  • Population : Patients having a diagnostic of pseudoaneurysm of the greater palatine artery who had an autogenous connective tissue gingival graft
  • Intervention : Patients treated with local hemostatic agents or by angiographic embolization
  • Comparison : None

Exclusion Criteria:

  • Missing data in patients' chart precluding complete data extraction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454490


Contacts
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Contact: Simon Jean, DMD 1-418-649-0252 ext 63972 simon.jean.4@ulaval.ca
Contact: Marianne Bouchard-Asselin, DMD 1-418-649-0252 ext 63972 marianne.bouchard-asselin.1@ulaval.ca

Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
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Study Director: Melinda Paris, DMD, FRCD Hopital de l'Enfant-Jesus, CHU de Quebec, Laval University
More Information
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Publications:

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Responsible Party: Simon Jean, Principal Investigator, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT03454490    
Other Study ID Numbers: Postoperative pseudoaneurysm
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Jean, Hopital de l'Enfant-Jesus:
Gingival graft
Pseudoaneurysm
Postoperative complication
 Gingival recession treatment
Palatine mass
Palatine bleeding
Additional relevant MeSH terms:
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Aneurysm, False
Aneurysm
Vascular Diseases
Cardiovascular Diseases