Skip to main content
OpenTrials
Completed

NCT Number: NCT06527053

Digital Obturators in Maxillectomy Cases

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Device Malfunction

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eman Nasr

Tanta, Gharbia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

obturator

Device

special maxillofacial device to close hollow defects

Primary outcomes

  1. Evaluation of hypernasality in speech

    Time frame: one month

    physiologic parameter

  2. Evaluation of masseter muscle muscle

    Time frame: three months

    physiologic parameter

  3. Evaluation of Patient Quality of Life

    Time frame: six months

    questionnaire

  4. Evaluation of retention

    Time frame: 1 day (at time of device insertion)

    descriptive by KP scale

  5. Obturator misfit

    Time frame: 1 day (at time of device delivery)

    descriptive by Digital software

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.