CompletedNCT06527053Updated Jul 30, 2024

Digital Obturators in Maxillectomy Cases

An interventional study of obturator in Device Malfunction, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Tanta University · Not applicable, Interventional, and Device feasibility

From the registry’s dates

Primary completion was May 2022, 4 years 5 months ago, and no results have been posted to the registry.
Registered 2 years 3 months after the study started (first participant enrolled Dec 2021, registered Apr 2024).

Phase: Not applicable
Study type: Interventional
Enrollment: 7
Allocation: Randomized
Ages: 20 Years to 70 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Device Malfunction

Keywords

digital obturators-roofless design-maxillectomy-mucorycosis

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Device feasibility
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Care provider)
Enrollment: 7 participants (actual)

Study arms

Experimental
digital obturator
new approach to create device
Device: obturator
Experimental
conventional obturator
old approach to create device
Device: obturator

Interventions

Deviceobturator
special maxillofacial device to close hollow defects

What researchers measure

Primary outcomes

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

Study locations

1 site

Eman Nasr
Tanta, Gharbeya, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06527053
Lead sponsor: Tanta University
Responsible party: Eman Nasr (Assistant Lecturer Eman Nasr, Tanta University) — Principal investigator
First posted: Jul 30, 2024
Start date: Dec 21, 2021
Primary completion: May 1, 2022
Completion: Jan 7, 2024
Last update: Jul 30, 2024

Study contacts

ali al shaikh, professor

principal investigator · Tanta University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Tanta University

Start the discussion