The Effect of Osseodensification on Implant Stability in Posterior Maxilla

December 31, 2024 updated by: Sara Amr Abdel Raouf, Cairo University

Assessment of Dental Implants Stability After Using Osseodensification Method Versus Conventional Drilling in the Posterior Maxilla: A Randomized Clinical Trial

Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Insertion torque will be evaluated at the termination of implant placement and crestal bone loss will be measured post-implant insertion, after 3 months and after 6 and 12 months of loading. Post-operative pain and patients' satisfaction will be assessed as well. implant survival will be assessed at the end of the follow up period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: >18 years; medically free,
  • Partially edentulous patients in maxillary posterior area (premolar-molar area)
  • Sufficient ridge height
  • Sufficient ridge width
  • Adequate soft tissue biotype.
  • Patients with adequate inter-arch space for placement of implant prosthetic part.
  • Cooperative patients with good oral hygiene
  • Patients who accept to sign an informed consent.

Exclusion Criteria:

  • Active periodontal diseases
  • Parafunctional habits.
  • History of radiation therapy to the head and neck
  • Bone augmentation to implant site
  • Smoking
  • Pregnant females

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
Experimental: Densah burs
Osseodensification using Densah burs
Device: Densah Burs
osseodensification method
Active Comparator: Standard drills
conventional drilling using standard drills
Device: Standard drills
conventional drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months
Implant stability will be measured using Osstell (Resonance Frequency Analysis). the measurement unit is Implant stability quotient (ISQ) (range 1-100)
immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal bone loss
Time Frame: immediately post-implant insertion - 3 months- 6 and 12 months post-loading
Standardized periapical digital radiographs
immediately post-implant insertion - 3 months- 6 and 12 months post-loading
Insertion torque
Time Frame: at the termination of implant insertion
torque wrench
at the termination of implant insertion

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Omnia Aboul Dahab, Professor, Faculty of Dentistry, Cairo 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)

January 3, 2021

Primary Completion (Actual)

December 10, 2022

Study Completion (Actual)

December 20, 2023

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 31, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sara89

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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