PseudoaneurysmNCT03454490
Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series
An observational study of Pseudoaneurysm, run by Hopital de l'Enfant-Jesus.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudoaneurysm
- What is being tested?
- Postoperative pseudoaneurysm of the greater palatine artery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients having a diagnostic of pseudoaneurysm of the greater palatine artery who had an autogenous connective tissue gingival graft
Who may be able to join
- 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
Who cannot join
- Missing data in patients' chart precluding complete data extraction
Trial locations and contacts
No sites are listed yet.
Marianne Bouchard-Asselin, DMD contact
About this study
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.
- Conditions
- Pseudoaneurysm
- Being tested
- Postoperative pseudoaneurysm of the greater palatine artery
- Keywords
- Gingival graft, Pseudoaneurysm, Postoperative complication, Gingival recession treatment, Palatine mass, Palatine bleeding
- Medical subject headings
- Aneurysm, False, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative pseudoaneurysm of the greater palatine arteryProcedure or surgery
Patients had an autogenous connective tissue gingival graft.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative oral bleeding
Complication following autogenous connective tissue gingival graft
Measured: One month following autogenous connective tissue gingival graft
Secondary outcomes (3)
Use of local hemostatic agents
Palliative method before definitive care
Measured: Six months
Secondary effects following angiographic intervention
Postoperative infection, bone or gum necrosis, extrusion of embolization material, loss of tooth, tooth devitalization following angiographic intervention
Measured: Six months
Number of followups required
Secondary effects following angiographic intervention
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PseudoaneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Jean, Hopital de l'Enfant-Jesus
- Investigators
- Melinda Paris, DMD, FRCD, Study director, Hopital de l'Enfant-Jesus, CHU de Quebec, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454490
- Sponsor's protocol ID
- Postoperative pseudoaneurysm
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29424485Tozum 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.
PubMed 16274302Byun 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.
PubMed 19485822Thomas 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.
PubMed 23375075
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series
- ClinicalTrials.gov ID
- NCT03454490
- Acronym / sponsor ID
- Postoperative pseudoaneurysm
- Conditions
- Pseudoaneurysm
- Keywords
- Gingival graft, Pseudoaneurysm, Postoperative complication, Gingival recession treatment, Palatine mass, Palatine bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients having a diagnostic of pseudoaneurysm of the greater palatine artery who had an autogenous connective tissue gingival graft
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Missing data in patients' chart precluding complete data extraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative pseudoaneurysm of the greater palatine arteryPatients had an autogenous connective tissue gingival graft. | Procedure or surgery | – |
Primary outcome
Postoperative oral bleeding
Time frame: One month following autogenous connective tissue gingival graft
Complication following autogenous connective tissue gingival graft
3 secondary outcomes
Use of local hemostatic agents
Time frame: Six months
Secondary effects following angiographic intervention
Time frame: Six months
Number of followups required
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Background: PubMed 29424485Yadav 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.
- Background: PubMed 16274302Tozum 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.
- Background: PubMed 19485822Byun 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.
- Background: PubMed 23375075Thomas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Bouchard-Asselin, DMD contact
Melinda Paris, DMD, FRCD study director
Hopital de l'Enfant-Jesus, CHU de Quebec, Laval University
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoaneurysm, run by Hopital de l'Enfant-Jesus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Jean, DMD (1-418-649-0252 ext. 63972, simon.jean.4@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative oral bleeding (time frame: One month following autogenous connective tissue gingival graft). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454490, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.