Digital Obturators in Maxillectomy Cases

Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases

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

Study Overview

• Status: Completed
• Conditions: Device Malfunction
• Intervention / Treatment: Device: obturator

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbeya
    • Tanta, Gharbeya, Egypt
      • Eman Nasr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital obturator; new approach to create device	Device: obturator; special maxillofacial device to close hollow defects
Experimental: conventional obturator; old approach to create device	Device: obturator; special maxillofacial device to close hollow defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of hypernasality in speech	physiologic parameter	one month
Evaluation of masseter muscle muscle	physiologic parameter	three months
Evaluation of Patient Quality of Life	questionnaire	six months
Evaluation of retention	descriptive by KP scale	1 day (at time of device insertion)
Obturator misfit	descriptive by Digital software	1 day (at time of device delivery)

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: ali al shaikh, professor, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): January 7, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: digital obturators-roofless design-maxillectomy-mucorycosis
• Other Study ID Numbers: RP08-21\4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes