NCT05358275

Brief Summary

to evaluate the percentage of bone volume regain along with postoperative pain in cases done using the bone lid technique in comparison with those done using the conventional cyst enucleation technique.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

April 28, 2022

Last Update Submit

April 28, 2022

Conditions

Odontogenic Cysts

Outcome Measures

Primary Outcomes (1)

  • Regain of bone volume

    evaluation of formed bone using CBCT

    6 months

Secondary Outcomes (1)

  • Pain with visual analogue scale

    one week

Study Arms (2)

study group

EXPERIMENTAL

Guided lid surgery is performed to reduce the loss of bone post operative

Device: surgical cutting guide with piezo

control group

ACTIVE COMPARATOR

The patient will receive active ordinary treatment for removal of odontogenic cysts

Other: control

Interventions

surgical cutting guide with piezoDEVICE

3D planned lid surgery

study group
controlOTHER

ordinary cyst enucleation

control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranging from 18-60 years.
  • Have free medical history or controlled systemic disease.
  • Expansile cystic lesion with intact cortical bone extending from 2-6 teeth.
  • A minimum thickness of 1 mm of the cortical bone.

You may not qualify if:

  • Patients with history of surgery in the area affected by the cystic lesion.
  • Patients with suspected malignant tumors in the area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams University

Cairo, 11757, Egypt

RECRUITING

MeSH Terms

Conditions

Odontogenic Cysts

Condition Hierarchy (Ancestors)

Jaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Study Officials

  • mohamed diaa

    Ain Shams University

    STUDY CHAIR

Central Study Contacts

yasser el hadidi

CONTACT

+201006596242yasserelhadidi@asfd.asu.edu.eg

Marwa El Kassaby

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial with 1:1 allocation ratio
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

March 1, 2023

Last Updated

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)