NCT06434441

Brief Summary

This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
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

August 10, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

May 23, 2024

Last Update Submit

January 19, 2025

Conditions

Bone Atrophy

Keywords

Bone graftIliac crest blocksCalverial bone blocksHorizontal bone gain

Outcome Measures

Primary Outcomes (1)

  • Horizontal bone gain

    the study compares the horizontal bone gain of reconstructed maxillary alveolar ridges after being augmented with calverial and iliac crest bone grafts radiographically by millimeters

    6 months consolidation period

Secondary Outcomes (1)

  • Immunohistochemical bone formation

    6 months consolidation period

Study Arms (2)

Study group:

ACTIVE COMPARATOR

The patients will receive calverial grafts, to reconstruct the deficient maxillary ridge

Procedure: Autogenous bone augmentation

Control group:

ACTIVE COMPARATOR

The patients will receive iliac crestgrafts, to reconstruct the deficient maxillary ridge

Procedure: Autogenous bone augmentation

Interventions

Autogenous bone augmentationPROCEDURE

Maxillary alveolar bone reconstruction

Control group:Study group:

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm

You may not qualify if:

  • Any previous maxillary reconstructive or dental implant treatment.
  • Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amr Gibaly

Cairo, 62764, Egypt

RECRUITING

Central Study Contacts

Amr Gibaly

CONTACT

01113336634amrgibaly@dent.bsu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking in not applicable for the patients or the operators
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A) The Study group: The patients within the study group will receive mono-cortical bone block calvarial grafts B) The Control group: The patients within the control group will receive mono-cortical bone block iliac crest grafts,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 30, 2024

Study Start

August 10, 2023

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)