Digital Obturators in Maxillectomy Cases

Not Applicable

Completed

• Conditions: Device Malfunction
• Interventions: Device: obturator

• Registration Number: NCT06527053
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study Start: 2021-12-21
• Primary Completion: 2022-05-01
• Study Completion: 2024-01-07
• Study First Submitted: 2024-04-15
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
digital obturator	obturator	new approach to create device
conventional obturator	obturator	old approach to create device

Primary Outcome Measures

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

Trial Locations

Locations (1)

Eman Nasr; 🇪🇬 Tanta, Gharbeya, Egypt