- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03454490
Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series
March 2, 2018 updated by: Simon Jean, Hopital de l'Enfant-Jesus
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders 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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative oral bleeding
Time Frame: One month following autogenous connective tissue gingival graft
|
Complication following autogenous connective tissue gingival graft
|
One month following autogenous connective tissue gingival graft
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of local hemostatic agents
Time Frame: Six months
|
Palliative method before definitive care
|
Six months
|
|
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
|
Six months
|
|
Number of followups required
Time Frame: Six months
|
Secondary effects following angiographic intervention
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Melinda Paris, DMD, FRCD, Hopital de l'Enfant-Jesus, CHU de Quebec, Laval University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yadav AP, Kulloli A, Shetty S, Ligade SS, Martande SS, Gholkar MJ. Sub-epithelial connective tissue graft for the management of Miller's class I and class II isolated gingival recession defect: A systematic review of the factors influencing the outcome. J Investig Clin Dent. 2018 Aug;9(3):e12325. doi: 10.1111/jicd.12325. Epub 2018 Feb 9.
- Tozum TF, Keceli HG, Guncu GN, Hatipoglu H, Sengun D. Treatment of gingival recession: comparison of two techniques of subepithelial connective tissue graft. J Periodontol. 2005 Nov;76(11):1842-8. doi: 10.1902/jop.2005.76.11.1842.
- Byun HY, Oh TJ, Abuhussein HM, Yamashita J, Soehren SE, Wang HL. Significance of the epithelial collar on the subepithelial connective tissue graft. J Periodontol. 2009 Jun;80(6):924-32. doi: 10.1902/jop.2009.080673.
- Thomas J, Patel NS, Viroslav A, Sheykholeslami K. Greater palatine artery pseudoaneurysm presenting as a slow-growing palatal mass. J Oral Maxillofac Surg. 2013 Apr;71(4):e164-7. doi: 10.1016/j.joms.2012.11.017. Epub 2013 Jan 29. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2018
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
February 22, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (Actual)
March 6, 2018
Study Record Updates
Last Update Posted (Actual)
March 6, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Postoperative pseudoaneurysm
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pseudoaneurysm
-
Changhai HospitalXiangya Hospital of Central South University; West China Hospital; First Affiliated... and other collaboratorsNot yet recruitingAortic Arch Aneurysm | Aortic Arch Pseudoaneurysm | Aortic Arch UlcerChina
-
University of MiamiTemporarily not availablePseudoaneurysm, Carotid | PseudoaneurysmUnited States
-
China National Center for Cardiovascular DiseasesActive, not recruitingAortic Dissection | Aortic Intramural Hematoma | Aneurysm, Aortic Arch | Aortic Pseudoaneurysm | Aortic Ulcer, PenetratingChina
-
Rigshospitalet, DenmarkCompleted
-
University Hospital, Basel, SwitzerlandNot yet recruitingAneurysm | Peripheral Arterial Disease(PAD) | Hemmorhage | Pseudoaneurysm | Acute Ischemia | Vascular Surgical ProcedureSwitzerland
-
Centre Hospitalier Universitaire de NiceCompletedLiver Injury | Pseudoaneurysm | Hepatic InjuryFrance
-
Chinese Academy of Medical Sciences, Fuwai HospitalPeking University People's Hospital; Beijing Hospital; China-Japan Friendship...UnknownUlcer | Aortic Dissection | Aortic Arch Aneurysm | PseudoaneurysmChina
-
Shanghai General Hospital, Shanghai Jiao Tong University...Active, not recruitingThoracic Aortic Dissection | Penetrating Aortic Ulcer | Thoracic Aortic Aneurysm (true Aneurysm) | Thoracic Pseudoaneurysm | Intramural Hematoma of the Thoracic AortaChina
-
Cook Research IncorporatedRecruitingStroke | Stenosis | TIA | Vascular Malformation | Pseudoaneurysm | Bleed IntracranialUnited States
-
W.L.Gore & AssociatesEnrolling by invitationAortic Dissection | Aortic Aneurysm, Thoracic | Aorta; Lesion | PseudoaneurysmUnited States
Clinical Trials on Postoperative pseudoaneurysm of the greater palatine artery
-
Dietrich-Bonhoeffer-KlinikumCompleted
-
Bozyaka Training and Research HospitalCompletedCatheterization, Peripheral | Radial Artery | Arterial Cannulation in Intensive Care UnitTurkey
-
Gaziosmanpasa Research and Education HospitalCompleted
-
Ospedale Policlinico San MartinoNot yet recruitingEndovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild SymptomsSubdural Hematoma, Chronic
-
University of ManitobaRecruitingSubdural HematomaCanada
-
University of OttawaCompletedCoronary Artery DiseaseCanada
-
IRCCS Policlinico S. DonatoActive, not recruitingAtherosclerosis | Stent ComplicationItaly
-
Lumen BiomedicalCompleted
-
Assistance Publique Hopitaux De MarseilleUnknown
-
Hospices Civils de LyonCompletedPeripheral Arterial Occlusive Disease | Critical Limb Ischemia | Arterial Revascularization | Arterial Bypass SurgeryFrance