NCT06095843

Brief Summary

The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction. The main question it aims to answer are: • evaluate the bony changes around dental implants and it's survival rate in both groups

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 2019

Longer than P75 for not_applicable

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 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

3.8 years

First QC Date

November 8, 2022

Last Update Submit

October 21, 2023

Conditions

Crestal Bone LossSurvival Rate

Outcome Measures

Primary Outcomes (3)

  • bony changes around dental implants

    measuring crestal bone loss (mm)

    1 year

  • survival rate of dental implants

    measuring survival rate of dental implants (%)

    1 year

  • stability of dental implants

    measuring primary and secondary stability (ISK)

    1 year

Study Arms (2)

implants in free vascularized fibular flap

ACTIVE COMPARATOR

placement of dental implants in free fibular flaps after mandibular reconstruction

Procedure: placement of dental implants

implants in non-vascularized iliac crest grafts

ACTIVE COMPARATOR

placement of dental implants in non-vascularized iliac crest grafts after mandibular reconstruction

Procedure: placement of dental implants

Interventions

placement of dental implantsPROCEDURE

placement of dental implants in mandibular reconstruction.

implants in free vascularized fibular flapimplants in non-vascularized iliac crest grafts

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients following traumatic injuries
  • gunshot injuries
  • tumor ablative surgeries
  • osteomylitis and osteonecrosis affecting the mandible

You may not qualify if:

  • cardiovascular or pulmonary disease
  • vascular or bone disorder
  • previous fractures or surgeries related to the donor site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 00000, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

November 8, 2022

First Posted

October 23, 2023

Study Start

January 1, 2019

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)