Digital Obturators in Maxillectomy Cases

Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06527053

Enrollment

Registered

2024-07-30

Start date

2021-12-21

Completion date

2024-01-07

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Device Malfunction

Keywords

digital obturators-roofless design-maxillectomy-mucorycosis

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.

Interventions

DEVICEobturator

special maxillofacial device to close hollow defects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DEVICE_FEASIBILITY

Masking

SINGLE (Caregiver)

Intervention model description

patients with maxillary defects had received two types of obturators

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026