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NCT Number: NCT07360015

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine - Egyptian Russian University

Cairo, 11829, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OT Equator abutments with 3 screws.

Other

screw retained implant supported mandibular prosthesis with OT Equator abutments (3 screws).

OT Equator abutments with 4 screws.

Other

screw retained implant supported mandibular prosthesis with OT Equator abutments (4 screws).

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Egyptian Russian University
  • Fayoum University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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