Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch

NCT ID: NCT06050187

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2024-12-17

Brief Summary

This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.

Conditions

Prosthesis Durability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I conventional stone cast

Mandibular stone cast with 4 parallel implants analogues in canines and second premolar regions will be fabricated conventionally.

Group Type: ACTIVE_COMPARATOR

implant casts fabrication

Intervention Type: PROCEDURE

four implant casts fabricated

Group II 3D printed implant cast

3D printed implant mandibular cast with 4 parallel digital implants analogues in canines and second premolar regions will be fabricated digitally.

Group Type: ACTIVE_COMPARATOR

implant casts fabrication

Intervention Type: PROCEDURE

four implant casts fabricated

Interventions

implant casts fabrication

four implant casts fabricated

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history.

• Patients were free from all oral pathological conditions and any remaining roots which were verified by pre-operative panoramic radiograph.
• Patients with U shaped arch, flat mandibular alveolar ridge covered with even compressibility healthy mucosa and gingival thickness of about 2mm verified by dual scan of cone beam computed tomography (CBCT) during treatment planning. Fig.(1)
• Adequate residual alveolar bone quality D2 bone type in the anterior and premolar regions according to the Misch bone density classification scheme (850 to1250 housefield units) confirmed by CBCT.
• Angel's class I maxillomandibular relation with moderate inter- arch space (20 mm) confirmed through tentative jaw relationship, and restorative space of at least 15 mm determined by putty index technique
• Patients complain from poor retentive mandibular denture seeking for alternative fixed options.
• Patient who is motivated, agreed with the follow-up visits and willing to return for follow-up appointments.

Exclusion Criteria

• • Patient with absolute contraindications that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy.

• Patient with relative contraindication such as UN controlled diabetes mellitus, moderate smoking and alcoholism, patient with TMJ disorder and heavy smokers for more than10 cigarettes per day.
• Patient with local contra indication as insufficient bone quality, localized lesion in canine area and premolar area, unfavourable position of the lower alveolar or mental nerve, bone defects as verified by cone beam CT.
• Uncooperative patient.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

A07030123

Identifier Type: -

Identifier Source: org_study_id