Bone Level Evaluation Around Implants in All on Four Hybrid Restorations With Different Connections (Radiographic Evaluation)

NCT ID: NCT07333235

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-14
• Study Completion Date: 2025-05-30

Brief Summary

this research aims to compare between using multiunit abutments and OT Equator abutments for constructing implant supported fixed mandibular prosthesis regarding the marginal bone height alteration around the implants through radiographic evaluation

Detailed Description

Patient selection:

Fourteen completely edentulous male patients free from any systemic diseases that would affect bone metabolism, had no history of recent administration of chemotherapy or radiotherapy and no history of para-functional habits will be selected from out-patients clinic.

Grouping of patients:

The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with multiunit abutments.

The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments.

Pre-surgical protocol:

For each patient, upper and lower complete dentures will be constructed. Using dual CBCT scan protocol, stereolithographic surgical guide will be constructed according to virtual implant planning in the software.

Surgical protocol:

The 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.

For the first group, multiunit abutments will be screwed to the four implants. For the second group, OT EQUATOR abutments will be screwed to the four implants.

Denture conversion for temporization:

Trans-mucosal abutments will be used to convert the denture to a temporary fixed implant supported restoration and will be screwed on multiunit abutments of the first group and on OT EQUATOR abutments for the second group.

Delivery of final prosthesis:

After three months of implant insertion, the final prosthesis will be constructed and then screwed to the multiunit abutments for the first group and to the OT Equator abutments for the second group.

Radiographic Evaluation:

The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.

Statistical analysis:

Bone loss measurements will be tabulated and statistically analyzed.

Conditions

Bone Loss in Jaw

Study Design

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

Study Groups

multiunit abutments

multiunit abutments will be used to support the implant-supported prostheses

Group Type: EXPERIMENTAL

different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis

Intervention Type: OTHER

for one group, multiunit abutments will be screwed to the four implants to support the prosthesis.

for the second group, OT EQUATOR abutments will be screwed to the four implants to support the prosthesis.

OT EQUATOR abutments

OT EQUATOR abutments will be used to support the implant-supported prostheses

Group Type: EXPERIMENTAL

different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis

Intervention Type: OTHER

for one group, multiunit abutments will be screwed to the four implants to support the prosthesis.

for the second group, OT EQUATOR abutments will be screwed to the four implants to support the prosthesis.

Interventions

different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis

for one group, multiunit abutments will be screwed to the four implants to support the prosthesis.

for the second group, OT EQUATOR abutments will be screwed to the four implants to support the prosthesis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• completely edentulous patients
• male patients
• free from any systemic diseases
• no history of recent administration of chemotherapy or radiotherapy
• no history of para-functional habits

Exclusion Criteria

• female patients
• diabetic patients and patients with bone metabolism diseases
• history of recent administration of chemotherapy or radiotherapy
• history of para-functional habits
• Heavy smokers.
• Heavy consumption of Alcohol

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Egyptian Russian University

NETWORK

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Oral and Dental Medicine - Egyptian Russian University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FD-ERU-Rec 24

Identifier Type: -

Identifier Source: org_study_id