Clinical Evaluation of Fenestration Decompression Combined With Secondary Curettage for Ameloblastoma of the Jaw: Retrospective Radiographic Analysis

Objectives: To investigate the outcomes of fenestration decompression combined with secondary curettage (FDSC) in the surgical treatment of jaw ameloblastoma.

Methods: Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: FDSC group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups. A total of 233 eligible patients were selected for provisional screening, including 145 patients with MA, and 88 patients with UA.

Study Overview

• Status: Completed
• Conditions: Cystic Cavity Area Reduction Efficiency; the Recurrence of the Tumor
• Intervention / Treatment: Procedure: fenestration decompression combined with secondary curettage

• Study Type: Observational
• Enrollment (Actual): 233

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: fenestration decompression combined with secondary curettage (FDSC) group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups.

Description

Inclusion Criteria:

-Medical records of patients who were diagnosed with multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital of Shanghai JiaoTong University Medical College.

Exclusion Criteria:

• followed up less than 3 years
• For FDSC group, fenestration decompression failed
• recurrent ameloblastoma
• received other type of surgery;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fenestration decompression combined with secondary curettage (FDSC); Design of the opening window reasonably；Making cyst plug；secondary curettage	Procedure: fenestration decompression combined with secondary curettage; First，fenestration decompression was performed. then, patients return every 3 months for follow up. If the cystic cavity area was gradually reduced after one year of follow-up, patients should be considered for secondary curettage surgery.
local curettage (LC); The tumor was removed by local curettage only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cystic cavity area reduction efficiency	(good effect case number + moderate effect case number)/total case number	3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor recurrence rate	the recurrence case number/total case number	3 years after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
malignant transformation rate	malignant transformation case number/total case number	3 years after surgery

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Odontogenic Tumors; Recurrence; Ameloblastoma
• Other Study ID Numbers: 123456 (Innovate UK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No