NCT06536907

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

July 31, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

biopsydiagnosiskeratocystsodontogenic cystsoral pathologysurgical decompression

Outcome Measures

Primary Outcomes (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

    A decompression period ranging between 2 and 15 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (18)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Awni S, Conn B. Decompression of keratocystic odontogenic tumors leading to increased fibrosis, but without any change in epithelial proliferation. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Jun;123(6):634-644. doi: 10.1016/j.oooo.2016.12.007. Epub 2016 Dec 30.

  • Rodu B, Tate AL, Martinez MG Jr. The implications of inflammation in odontogenic keratocysts. J Oral Pathol. 1987 Nov;16(10):518-21. doi: 10.1111/j.1600-0714.1987.tb00684.x.

  • Zhang L, Liu SL, Ye WM, Zheng J. STAT3 is a key pathway in primary intraosseous squamous cell carcinoma arising from an odontogenic keratocyst. Am J Transl Res. 2015 Oct 15;7(10):1860-9. eCollection 2015.

MeSH Terms

Conditions

Odontogenic CystsRadicular CystDisease

Condition Hierarchy (Ancestors)

Jaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesPeriodontal CystPeriapical DiseasesPeriodontal DiseasesMouth DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 5, 2024

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

September 1, 2023

Last Updated

August 5, 2024

Record last verified: 2024-07

Locations