NCT03454490

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

February 22, 2018

Last Update Submit

March 2, 2018

Conditions

Keywords

Gingival graftPseudoaneurysmPostoperative complicationGingival recession treatmentPalatine massPalatine bleeding

Outcome Measures

Primary Outcomes (1)

  • Postoperative oral bleeding

    Complication following autogenous connective tissue gingival graft

    One month following autogenous connective tissue gingival graft

Secondary Outcomes (3)

  • Use of local hemostatic agents

    Six months

  • Secondary effects following angiographic intervention

    Six months

  • Number of followups required

    Six months

Interventions

Patients had an autogenous connective tissue gingival graft.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having a diagnostic of pseudoaneurysm of the greater palatine artery who had an autogenous connective tissue gingival graft

You may qualify if:

  • 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

You may not qualify if:

  • Missing data in patients' chart precluding complete data extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29424485BACKGROUND
  • 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.

    PMID: 16274302BACKGROUND
  • 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.

    PMID: 19485822BACKGROUND
  • 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.

    PMID: 23375075BACKGROUND

MeSH Terms

Conditions

Aneurysm, FalsePostoperative Complications

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Melinda Paris, DMD, FRCD

    Hopital de l'Enfant-Jesus, CHU de Quebec, Laval University

    STUDY DIRECTOR

Central Study Contacts

Marianne Bouchard-Asselin, DMD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 6, 2018

Study Start

March 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share