Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.

June 26, 2024 updated by: Amr Gibaly, Beni-Suef University

ASSESSMENT OF DENTAL IMPLANTS PLACED IN MANDIBULAR CONSOLIDATED ILIAC-CREST BONE GRAFTS USING DENSAH BURS VERSUS THE STANDARD DRILLS (A Randomized Controlled Trial)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test group
The dental implants placed after bone osseodensification using densah burs
Procedure: Dental implants placement
implants placed in consolidated bone grafts
Active Comparator: Control group
The dental implants placed after conventional bone drilling with the standard drills
Procedure: Dental implants placement
implants placed in consolidated bone grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic bone loss
Time Frame: 6 months osseointegration period
Calibration of the amplitude of vertical bone loss
6 months osseointegration period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: 6 months osseointegration period
Calibration of primary and secondary implant stability quotient
6 months osseointegration period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Estimated)

June 27, 2024

Study Record Updates

Last Update Posted (Estimated)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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