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OpenTrials
Completed

NCT Number: NCT04987515

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

fenestration decompression combined with secondary curettage

Procedure

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.

Primary outcomes

  1. Cystic cavity area reduction efficiency

    Time frame: 3 years after surgery

    (good effect case number + moderate effect case number)/total case number

Secondary outcomes

  1. Tumor recurrence rate

    Time frame: 3 years after surgery

    the recurrence case number/total case number

Other outcomes

  1. malignant transformation rate

    Time frame: 3 years after surgery

    malignant transformation case number/total case number

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.