Digital Obturators in Maxillectomy Cases

NCT06527053 | Completed DMC FDA Device

• 1 other identifier: RP08-21\4
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Device Malfunction

Keywords

digital obturators-roofless design-maxillectomy-mucorycosis

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

digital obturator

EXPERIMENTAL

new approach to create device

Device: obturator

conventional obturator

EXPERIMENTAL

old approach to create device

Device: obturator

Interventions

obturator DEVICE

special maxillofacial device to close hollow defects

conventional obturator; digital obturator

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Eman Nasr

Tanta, Gharbia Governorate, Egypt

Location

Study Officials

• ali al shaikh, professor

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Eman Nasr

Model Details: patients with maxillary defects had received two types of obturators

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: July 30, 2024
• Study Start: December 21, 2021
• Primary Completion: May 1, 2022
• Study Completion: January 7, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)