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

Primary Purpose

Facial Asymmetry

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Prosthetic intervention with maxillary obturator prosthesis

About this trial

This is an interventional treatment trial for Facial Asymmetry

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hoor NafadeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

obturator group(unilalateral maxillary defect)

Control group

Arm Description

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.

intact side of the same patient

Outcomes

Primary Outcome Measures

Facial morphology

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05310149

First Posted

March 25, 2022

Last Updated

March 25, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05310149

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 7, 2022 (Actual)

Primary Completion Date

October 15, 2022 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Asymmetry

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

obturator group(unilalateral maxillary defect)

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

intact side of the same patient

Intervention Type

Device

Intervention Name(s)

Prosthetic intervention with maxillary obturator prosthesis

Intervention Description

Primary Outcome Measure Information:

Title

Facial morphology

Description

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

Time Frame

after 6 months of maxillofacial surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hoor Nafae

Phone

00201006268582

Hoor.mahmoud@dentistry.cu.edu.eg

Facility Information:

Facility Name

Hoor Nafade

City

Zagazig

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hoor Nafae

Phone

00201006268582

12. IPD Sharing Statement

Learn more about this trial

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

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