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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05310149
Other study ID # 7122
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 7, 2022
Est. completion date January 1, 2023

Study information

Verified date March 2022
Source Cairo University
Contact Hoor Nafae
Phone 00201006268582
Email Hoor.mahmoud@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Functional rehabilitation and quality of life after maxillofacial surgery have been emphasized in recent years. It depends mainly on outcomes of maxillofacial reconstruction and rehabilitation involving functions, esthetics, psychology acceptance and resocialization. Tooth loss, alveolar and maxillary bone resorption or changes of the hard palate cause facial asymmetry in patient with maxillofacial surgery. The facial soft tissue over the defect become recessed as a result of loss of lip and buccal support which lead to decrease the quality of life and psychological disorders. Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. The purpose of this study is to investigate the influence of maxillary obturator on facial morphology in patient with unilateral maxillary defect by using 3 dimensional digital stereophotogrammetry compared to the intact side of the same patient


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date January 1, 2023
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - adult patient of both sexes, 6 months after partial maxillectomy with good periodontal condition of remaining tooth especially abutment tooth. Exclusion Criteria: - patient with history of radiotherapy, bad oral hygiene patient with tumor recurrence, patient with mental instability, patient with systemic disorders like uncontrolled diabetes, compromised heart function

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Prosthetic intervention with maxillary obturator prosthesis
Prosthetic intervention with maxillary obturator prosthesis is necessary to restore the contours of the resected palate and to recreate the functional separation of the oral cavity and sinus and nasal cavities. Followings are the objectives of maxillary obturator Restoration of esthetics or cosmetic appearance of the patient, Restoration of function, Protection of tissues, Therapeutic or healing effect and psychological therapy.

Locations

Country Name City State
Egypt Hoor Nafade Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facial morphology 3 dimensional digital stereophotogrammetry compared to the intact side of the same patient. after 6 months of maxillofacial surgery
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