NCT06477874

Brief Summary

The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability. In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants. This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 21, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

Bone graftIliac crestImplant stability

Outcome Measures

Primary Outcomes (1)

  • Radiographic bone loss

    Calibration of the amplitude of vertical bone loss

    6 months osseointegration period

Secondary Outcomes (1)

  • Implant stability

    6 months osseointegration period

Study Arms (2)

Test group

ACTIVE COMPARATOR

The dental implants placed after bone osseodensification using densah burs

Procedure: Dental implants placement

Control group

ACTIVE COMPARATOR

The dental implants placed after conventional bone drilling with the standard drills

Procedure: Dental implants placement

Interventions

implants placed in consolidated bone grafts

Control groupTest group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both sexes with an age range of 18-55 years.
  • Patients subjected to a successful iliac crest mandibular bone graft after segmental mandibular resection.
  • A minimal ridge height of ten millimeters and a ridge width of seven millimeters.
  • Healthy soft tissue coverage, with a reasonable interaction space.

You may not qualify if:

  • Clinical or radiographic signs of graft infection, rejection, or massive resorption.
  • The previous exposure to radiotherapy or chemotherapy.
  • Any systemic disease that would affect bone healing or implant osseointegration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.

Cairo, Egypt

RECRUITING

Central Study Contacts

Maged Seleet, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 27, 2024

Study Start

June 9, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations