Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique

NCT ID: NCT05584865

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-05-01

Brief Summary

Different techniques of fabricating conventional custom-made ocular prosthesis were described. Traditional methods of custom fabricated ocular prosthesis had some limitations and take a long time, facial scanning and computed tomography will facilitate the full digital ocular prosthesis fabrication. Full digital ocular prosthesis is an innovated new technique to produce more accurate & more esthetic ocular prosthesis with less time consumed, however very few articles are available comparing between the full digital technique & the conventional one in manufacturing ocular prosthesis.

Conditions

Occluar Prosthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

Group Type: EXPERIMENTAL

Digital occluar prosthesis

Intervention Type: OTHER

Each patient will receive the full digital fabricated ocular prosthesis. DICOM data from the Computerized Tomography (CT) will be imported into Materializes Interactive Medical Image Control System (MIMICS) software++++ tool for visualizing and segmenting medical images (such as CT and MRI)

Group II

Group Type: ACTIVE_COMPARATOR

Conventional occluar prosthesis

Intervention Type: OTHER

An accurate impression of the patient's eye socket will be obtained to prepare a suitable wax mod. The wax model will be flasked and processed into heat cured acrylic resin of the same colour of the sclera of the other healthy eye of the patient

Interventions

Digital occluar prosthesis

Each patient will receive the full digital fabricated ocular prosthesis. DICOM data from the Computerized Tomography (CT) will be imported into Materializes Interactive Medical Image Control System (MIMICS) software++++ tool for visualizing and segmenting medical images (such as CT and MRI)

Intervention Type: OTHER

Conventional occluar prosthesis

An accurate impression of the patient's eye socket will be obtained to prepare a suitable wax mod. The wax model will be flasked and processed into heat cured acrylic resin of the same colour of the sclera of the other healthy eye of the patient

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have enough ocular bed to accommodate the ocular prosthesis.
• At least 3 months after surgery to allow complete healing of the socket.

Exclusion Criteria

• Patients under steroid therapy or those under radio or chemotherapy.
• Patients having eye lid deformity.
• History of psychological disorder.
• systemic disease.
• eye infection.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alexandria Faculty of Dentistry

Alexandria, , Egypt

Countries

Egypt

Central Contacts

yassmin A Tahmawy, Msc

Role: CONTACT

yasmin.gad@alexu.edu.eg

01064680829

Facility Contacts

Yassmin A Tahmawy, MSc

Role: primary

yasmin.gad@alexu.edu.eg

01064680829

References

Tahmawy YA, Mohamed FS, Elfeki S, Abd-Ellah ME. Microbiological evaluation of conjunctival anopthalmic flora after using digital 3D-printed ocular prosthesis compared to conventional one: a randomized clinical trial. BMC Oral Health. 2023 Dec 18;23(1):1012. doi: 10.1186/s12903-023-03746-w.

Reference Type: DERIVED

PMID: 38110937 (View on PubMed)

Other Identifiers

digital prosthesis_2022

Identifier Type: -

Identifier Source: org_study_id