Digital Obturators in Maxillectomy Cases

NCT ID: NCT06527053

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-21

Study Completion Date

2024-01-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Using Digital approach to treat patients with maxillofacial defects without surgical intervention

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Evaluating digital dental and maxillofacial obturators to artifitially close maxillofacial defects in paients with oral cancer and patients with mucormycosis fungal post covid infection.

Craeting Digitized database for all patients included in the study.

Recording casses with post covid infection in specific period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Device Malfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients with maxillary defects had received two types of obturators
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

digital obturator

new approach to create device

Group Type EXPERIMENTAL

obturator

Intervention Type DEVICE

special maxillofacial device to close hollow defects

conventional obturator

old approach to create device

Group Type EXPERIMENTAL

obturator

Intervention Type DEVICE

special maxillofacial device to close hollow defects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

obturator

special maxillofacial device to close hollow defects

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

All participants in this study will be selected according to the following criteria:

* Patients with maxillary defects Class I and class II Aramany Classification with completely healed tissues.
* Patients' age ranging from 20 to 70 years old.
* Nearly intact mandibular arch.

Exclusion Criteria

\-

Participants with the following criteria will be excluded from the study:

* Physical or mental instability.
* Completely edentulous patients.
* Patients presenting allergy to materials being used.
* Patients lacking compliance to maintain acceptable oral hygiene.
* Patients taking radiotherapy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eman Nasr

Assistant Lecturer Eman Nasr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ali al shaikh, professor

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eman Nasr

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RP08-21\4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Complete Digital Workflow
NCT07091786 ENROLLING_BY_INVITATION PHASE2/PHASE3