NCT07333235

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

January 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

January 1, 2026

Last Update Submit

January 1, 2026

Conditions

Bone Loss in Jaw

Keywords

implant-supported prosthesesOT abutmentmulti-unit abutmentcrestal 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 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.

    12 months

Study Arms (2)

multiunit abutments

EXPERIMENTAL

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

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

OT EQUATOR abutments

EXPERIMENTAL

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

Other: different types of abutments (multiunit abutments OR 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 prosthesisOTHER

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 abutmentsmultiunit abutments

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 1, 2026

First Posted

January 12, 2026

Study Start

January 14, 2024

Primary Completion

May 14, 2024

Study Completion

May 30, 2025

Last Updated

January 12, 2026

Record last verified: 2025-06

Locations

EG(1)