NCT04421144

Brief Summary

In this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

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

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 4, 2020

Last Update Submit

June 5, 2020

Conditions

Evaluation of the Accuracy of Transferring the Virtual Planning to the Surgery

Keywords

CAD/CAMorthognathic surgeryvirtual planningcutting guidescustomized titanium plates

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the surgical transfer

    Computer software on pre/postoperative CBCT

    within first week postoperatively

Secondary Outcomes (1)

  • Patient satisfaction: Visual analog scale (questionnaire)

    one week postoperative

Study Arms (1)

study group

EXPERIMENTAL

using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.

Procedure: orthognathic surgery

Interventions

orthognathic surgeryPROCEDURE

patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.

study group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
  • Patients with no signs or symptoms of active TMDs.
  • Highly motivated patients.

You may not qualify if:

  • Patients who refused to be included in the research.
  • Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
  • Patients with intra-bony lesions or infections that may retard the osteotomy healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Orthognathic Surgery

Intervention Hierarchy (Ancestors)

Surgery, OralDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL