All on Four Versus All on Three Implant Treatment Concepts

NCT ID: NCT05912127

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-16
• Study Completion Date: 2023-06-11

Brief Summary

the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.

Detailed Description

Patients will be classified into 2 groups according to the implant treatment concept they received:

• Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
• Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.

Conditions

Prosthesis Durability

Study Design

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

Study Groups

• Group 1 (control group)

patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.

Group Type: ACTIVE_COMPARATOR

implant supported fixed full arch prosthesis

Intervention Type: DEVICE

the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.

• Group 2 (test group);

patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.

Group Type: ACTIVE_COMPARATOR

implant supported fixed full arch prosthesis

Intervention Type: DEVICE

the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.

Interventions

implant supported fixed full arch prosthesis

the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.

2. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.

3. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.

Exclusion Criteria

1. Any neuromuscular disorders 2. Uncooperative patients

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• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mostafa Elsyad, professor

Role: PRINCIPAL_INVESTIGATOR

professor of prosthodontics, Faculty of dentistry , Mansoura University

Locations

Christine Ibrahim

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

A09071221

Identifier Type: -

Identifier Source: org_study_id