Radiographic Evaluation of Bone Level Evaluation Around Implants in All on Four Hybrid OT Restorations With Different Number of Screws

January 14, 2026 updated by: Ain Shams University
This research aims to compare between using OT Equator abutments for constructing implant supported fixed mandibular prosthesis with different number of screws (3 screws vs 4 screws) regarding the marginal bone height alteration around the implants through radiographic evaluation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

The first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).

The second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).

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

OT EQUATOR abutments will be screwed to the four implants. Denture conversion was done for temporization:

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

For the first group one screw will be avoided and the final prosthesis will be screwed to the OT Equator abutments with 3 screws only.

For the second group and the final prosthesis will be screwed to the OT Equator abutments with 4 screws.

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. Bone loss measurements will be tabulated and statistically analyzed.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11829
        • Faculty of Oral and Dental Medicine - Egyptian Russian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 screws
screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
Other: OT Equator abutments with 3 screws.
screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).
Experimental: 4 screws
screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).
Other: OT Equator abutments with 4 screws.
screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crestal bone loss around implants
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Fayoum University
Egyptian Russian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FD-ERU-Rec 25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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