Comparative Assessment of Primary Stability by Osseodensification Using Densah Burs Conventional Drilling Methods.

May 7, 2026 updated by: Suez Canal University
This clinical study evaluates and compares the primary stability of dental implants placed using osseodensification with Densah burs versus conventional drilling methods. The goal is to determine whether osseodensification improves implant stability and bone density, especially in areas with low bone quality

Study Overview

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female patients
  • Patients requiring dental implant placement in areas with varying bone quality
  • Patients without systemic diseases that interfere with bone healing or implant success (e.g., uncontrolled diabetes mellitus or osteoporosis)

Exclusion Criteria:

  • Patients with systemic diseases affecting bone metabolism
  • Presence of large periapical radiographic lesions related to the tooth to be extracted (abscess, granuloma, or cyst)
  • Teeth requiring transalveolar extraction
  • Patients with contraindications to surgical treatment
  • Patients with psychological disorders
  • Patients with uncontrolled medical conditions

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: controlled group conventional drilling group
Participants in this group will receive dental implants using the traditional drilling technique, which removes bone to create space for the implant.
"This group will receive implant site preparation using the conventional drilling technique, where bone is gradually removed to create space for the implant, as per standard implantology protocols."
Experimental: study group of osseodensification Group
Participants in this group will receive dental implants using the osseodensification technique with Densah burs, which preserves and compacts bone to enhance primary stability.
Participants will be divided into two groups. The first group will undergo implant site preparation using the osseodensification technique with Densah burs, which compacts bone and enhances primary stability without removing bone. The second group will undergo conventional drilling, where bone is removed in a stepwise manner to prepare the implant site according to standard surgical protocols."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Implant Stability Measured by Implant Stability Quotient (ISQ) Using the Osstell Device
Time Frame: Immediately after implant placement (within minutes)

Description:

Primary implant stability will be assessed immediately after implant placement using the Implant Stability Quotient (ISQ) obtained from the Osstell device. The ISQ scale ranges from 1 to 100, with higher values indicating greater implant stability.

Immediately after implant placement (within minutes)

Collaborators and Investigators

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

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 (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

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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