NCT05329974

Brief Summary

Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

3.3 years

First QC Date

April 6, 2022

Last Update Submit

April 12, 2022

Conditions

Odontogenic TumorsOdontoma

Outcome Measures

Primary Outcomes (1)

  • Intra-operative time

    Intra-operative time was measured from the start of the incision till suturing

    during the surgery

Secondary Outcomes (2)

  • Postoperative pain

    2, 5, and 10 days after the surgery

  • Edema

    5 and 10 days after the surgery

Study Arms (1)

Computer guided buccal cortical plate separation

EXPERIMENTAL

Computer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors

Other: Computer guided buccal cortical plate separation

Interventions

Computer guided buccal cortical plate separationOTHER

Computer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors

Computer guided buccal cortical plate separation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique

You may not qualify if:

  • Patients with any medical condition contraindicating the surgical procedures were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of dentistry, Cairo university

Cairo, 11728, Egypt

Location

Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (1)

  • Omara M, Gouda A, Ali S. Computer-guided buccal cortical plate separation for removal of calcified benign odontogenic tumors affecting the mandibular angle region. Maxillofac Plast Reconstr Surg. 2022 Sep 22;44(1):30. doi: 10.1186/s40902-022-00354-6.

    PMID: 36136180DERIVED

MeSH Terms

Conditions

Odontogenic TumorsOdontoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 15, 2022

Study Start

April 1, 2018

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

EG(2)