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Completed

NCT Number: NCT07333235

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

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

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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

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.

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

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

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.

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 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Egyptian Russian University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 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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