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Odontogenic CystsNCT06536907

Decompression of Odontogenic Cysts

An observational study of Odontogenic Cysts and Keratocysts of the Jaw, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this case-control study is to evaluate the effects of decompression of cystic jaw lesions by means of comparing pre- and post-decompression histologic findings. The main question it aims to answer is: Does decompression of cystic jaw lesions alter the histologic diagnosis? A retrospective analysis was… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2015to 1 Sep 2023
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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The study included patients with a histologic diagnosis of an odontogenic cystic lesion, that was surgically treated with decompression followed by a definitive surgery.

Who may be able to join

  • To have an initial diagnosis of an odontogenic cystic jaw lesion confirmed with an incisional biopsy.
  • The patients must have undergone decompression and, enucleation or enucleation and peripheral ostectomy after decompression period.

Who cannot join

  • Previously treated patients
  • The patients with missing information in medical and/or dental records
  • The patients who did not adhere to follow-up protocol

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Akdeniz University

    Antalya, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Decompression on Histologic Diagnoses of Cystic Jaw Lesions

The aim of this case-control study is to evaluate the effects of decompression of cystic jaw lesions by means of comparing pre- and post-decompression histologic findings.

The main question it aims to answer is:

Does decompression of cystic jaw lesions alter the histologic diagnosis?

A retrospective analysis was performed based on the comparison of initial and final histologic diagnoses of patients with an odontogenic cystic lesion, that was surgically treated with decompression followed by a definitive surgery.

Read the detailed description

The study included patients with a histologic diagnosis of an odontogenic cystic lesion, that was surgically treated with decompression followed by a definitive surgery. The study was carried out retrospectively by means of evaluating records, surgical and histologic reports of patients. Pre- and post-decompression histologic findings were compared in effort to understand if decompression leads to alteration in histologic character and change in diagnoses of lesions.

Keywords
biopsy, diagnosis, keratocysts, odontogenic cysts, oral pathology, surgical decompression
Medical subject headings
Odontogenic Cysts, Radicular Cyst, Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in histologic diagnosis following decompression (yes/no)

    A comparison will be made between the initial histologic diagnosis and post-decompression definitive histologic diagnosis of the cystic jaw lesions

    Measured: A decompression period ranging between 2 and 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2018
  4. Study completion1 Sep 2023

Resources

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-control
Time perspective
Retrospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06536907
Sponsor's protocol ID
70904504/553
Status last verified
Jul 2024
First submitted
31 Jul 2024
Last updated
5 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rajendra Santosh AB. Odontogenic Cysts. Dent Clin North Am. 2020 Jan;64(1):105-119. doi: 10.1016/j.cden.2019.08.002. Epub 2019 Oct 18.

    PubMed 31735221

  • Wakolbinger R, Beck-Mannagetta J. Long-term results after treatment of extensive odontogenic cysts of the jaws: a review. Clin Oral Investig. 2016 Jan;20(1):15-22. doi: 10.1007/s00784-015-1552-y. Epub 2015 Aug 8.

    PubMed 26250795

  • Oliveros-Lopez L, Fernandez-Olavarria A, Torres-Lagares D, Serrera-Figallo MA, Castillo-Oyague R, Segura-Egea JJ, Gutierrez-Perez JL. Reduction rate by decompression as a treatment of odontogenic cysts. Med Oral Patol Oral Cir Bucal. 2017 Sep 1;22(5):e643-e650. doi: 10.4317/medoral.21916.

    PubMed 28809378

  • Mohanty S, Dabas J, Verma A, Gupta S, Urs AB, Hemavathy S. Surgical management of the odontogenic keratocyst: A 20-year experience. Int J Oral Maxillofac Surg. 2021 Sep;50(9):1168-1176. doi: 10.1016/j.ijom.2021.02.015. Epub 2021 Mar 2.

    PubMed 33663899

  • Anavi Y, Gal G, Miron H, Calderon S, Allon DM. Decompression of odontogenic cystic lesions: clinical long-term study of 73 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Aug;112(2):164-9. doi: 10.1016/j.tripleo.2010.09.069. Epub 2010 Dec 30.

    PubMed 21194990

  • Pogrel MA, Jordan RC. Marsupialization as a definitive treatment for the odontogenic keratocyst. J Oral Maxillofac Surg. 2004 Jun;62(6):651-5; discussion 655-6. doi: 10.1016/j.joms.2003.08.029.

    PubMed 15170272

  • Schlieve T, Miloro M, Kolokythas A. Does decompression of odontogenic cysts and cystlike lesions change the histologic diagnosis? J Oral Maxillofac Surg. 2014 Jun;72(6):1094-105. doi: 10.1016/j.joms.2013.12.028. Epub 2014 Jan 15.

    PubMed 24576437

  • Allon DM, Allon I, Anavi Y, Kaplan I, Chaushu G. Decompression as a treatment of odontogenic cystic lesions in children. J Oral Maxillofac Surg. 2015 Apr;73(4):649-54. doi: 10.1016/j.joms.2014.10.024. Epub 2014 Oct 31.

    PubMed 25631867

  • Berretta LM, Melo G, Mello FW, Lizio G, Rivero ERC. Effectiveness of marsupialisation and decompression on the reduction of cystic jaw lesions: a systematic review. Br J Oral Maxillofac Surg. 2021 Dec;59(10):E17-E42. doi: 10.1016/j.bjoms.2021.03.004. Epub 2021 Mar 23.

    PubMed 34749963

  • August M, Faquin WC, Troulis MJ, Kaban LB. Dedifferentiation of odontogenic keratocyst epithelium after cyst decompression. J Oral Maxillofac Surg. 2003 Jun;61(6):678-83; discussion 683-4. doi: 10.1053/joms.2003.50137.

    PubMed 12796876

  • Nakamura N, Mitsuyasu T, Mitsuyasu Y, Taketomi T, Higuchi Y, Ohishi M. Marsupialization for odontogenic keratocysts: long-term follow-up analysis of the effects and changes in growth characteristics. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Nov;94(5):543-53. doi: 10.1067/moe.2002.128022.

    PubMed 12424446

  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Bull World Health Organ. 2007 Nov;85(11):867-72. doi: 10.2471/blt.07.045120.

    PubMed 18038077

  • Castro-Nunez J. Decompression of Odontogenic Cystic Lesions: Past, Present, and Future. J Oral Maxillofac Surg. 2016 Jan;74(1):104.e1-9. doi: 10.1016/j.joms.2015.09.004. Epub 2015 Sep 21.

    PubMed 26428611

  • Mustansir-Ul-Hassnain S, Chandavarkar V, Mishra MN, Patil PM, Bhargava D, Sharma R. Histopathologic and immunohistochemical findings of odontogenic jaw cysts treated by decompression technique. J Oral Maxillofac Pathol. 2021 May-Aug;25(2):272-278. doi: 10.4103/0973-029X.325126. Epub 2021 Aug 31.

    PubMed 34703121

  • Castro-Nunez J, Wiscovitch AG, Porte JP, Wiscovitch J, Rivera B, Guerrero LM. Does active decompression of odontogenic keratocyst change the histologic diagnosis? Oral Maxillofac Surg. 2022 Jun;26(2):291-298. doi: 10.1007/s10006-021-00994-4. Epub 2021 Jul 29.

    PubMed 34324108

Questions about this trial

What is this clinical trial studying?

An observational study of Odontogenic Cysts and Keratocysts of the Jaw, run by Akdeniz University at 1 site in Turkey (Türkiye).

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in histologic diagnosis following decompression (yes/no) (time frame: A decompression period ranging between 2 and 15 months). 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 NCT06536907, which also lists 18 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 5 Aug 2024.

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