NCT07360015

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Bone Loss in Jaw

Keywords

implant-supported prosthesesOT abutmentscrestal bone loss

Outcome Measures

Primary Outcomes (1)

  • crestal bone loss around implants

    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

Study Arms (2)

3 screws

EXPERIMENTAL

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

Other: OT Equator abutments with 3 screws.

4 screws

EXPERIMENTAL

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

Other: OT Equator abutments with 4 screws.

Interventions

OT Equator abutments with 3 screws.OTHER

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

3 screws
OT Equator abutments with 4 screws.OTHER

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

4 screws

Eligibility Criteria

Age40 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patients were only selected to avoid the effect of sex related variations as habits and physiology. Also, to avoid the effect of sex related hormonal changes which were reported to contribute to mucosal changes and osteoporosis.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine - Egyptian Russian University

Cairo, 11829, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

December 3, 2024

Primary Completion

March 10, 2025

Study Completion

February 1, 2026

Last Updated

January 22, 2026

Record last verified: 2025-01

Locations

EG(1)