Measuring the Influence of Maxillary Obturator Prosthesis on Facial Morphology in Patient With Unilateral Maxillary Defects Using Stereophotogrammetry

NCT05310149 | Unknown DMC

• 1 other identifier: 7122
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Facial Asymmetry

Outcome Measures

Primary Outcomes (1)

• Facial morphology

  3 dimensional digital stereophotogrammetry compared to the intact side of the same patient.

  after 6 months of maxillofacial surgery

Study Arms (2)

obturator group(unilalateral maxillary defect)

EXPERIMENTAL

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.

Device: Prosthetic intervention with maxillary obturator prosthesis

Control group

NO INTERVENTION

intact side of the same patient

Interventions

Prosthetic intervention with maxillary obturator prosthesis DEVICE

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.

obturator group(unilalateral maxillary defect)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patient of both sexes, 6 months after partial maxillectomy with good periodontal condition of remaining tooth especially abutment tooth.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hoor Nafade

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

Facial Asymmetry

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hoor Nafae

CONTACT

00201006268582; Hoor.mahmoud@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Candidate

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: January 7, 2022
• Primary Completion: October 15, 2022
• Study Completion: January 1, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

EG (1)