Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Evaluation of Patient Quality of Life
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
digital obturator
new approach to create device
Intervention: obturator (Device)
conventional obturator
old approach to create device
Intervention: obturator (Device)
Outcomes
Primary Outcomes
Evaluation of Patient Quality of Life
Time Frame: six months
questionnaire
Obturator misfit
Time Frame: 1 day (at time of device delivery)
descriptive by Digital software
Evaluation of retention
Time Frame: 1 day (at time of device insertion)
descriptive by KP scale
Evaluation of hypernasality in speech
Time Frame: one month
physiologic parameter
Evaluation of masseter muscle muscle
Time Frame: three months
physiologic parameter
Secondary Outcomes
No secondary outcomes reported
Investigators
Eman Nasr
Assistant Lecturer Eman Nasr
Tanta University