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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03454490
Other study ID # Postoperative pseudoaneurysm
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 22, 2018
Last updated March 2, 2018
Start date March 2018
Est. completion date July 2018

Study information

Verified date March 2018
Source Hopital de l'Enfant-Jesus
Contact Simon Jean, DMD
Phone 1-418-649-0252
Email simon.jean.4@ulaval.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Postoperative pseudoaneurysm of the greater palatine artery
Patients had an autogenous connective tissue gingival graft.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hopital de l'Enfant-Jesus

References & Publications (4)

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. — View Citation

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. — View Citation

Tözüm TF, Keçeli HG, Güncü GN, Hatipoglu H, Sengün D. Treatment of gingival recession: comparison of two techniques of subepithelial connective tissue graft. J Periodontol. 2005 Nov;76(11):1842-8. — View Citation

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 Feb 9. doi: 10.1111/jicd.12325. [Epub ahead of print] Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative oral bleeding Complication following autogenous connective tissue gingival graft One month following autogenous connective tissue gingival graft
Secondary Use of local hemostatic agents Palliative method before definitive care Six months
Secondary Secondary effects following angiographic intervention Postoperative infection, bone or gum necrosis, extrusion of embolization material, loss of tooth, tooth devitalization following angiographic intervention Six months
Secondary Number of followups required Secondary effects following angiographic intervention Six months
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