Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation

April 27, 2025 updated by: Hams Hamed Abdelrahman

Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation for Immediate Implant Placement in Mandibular Molars [Randomized Clinical Trial]

: Implant placement in the inter radicular septum is usually considered the best option for an immediate molar implant, not only in terms of correct 3D positioning, but also regarding implant survival, Osseodensification was shown to enhance implant primary stability, due to the compaction auto-grafting and the associated spring-back effect. Piezoelectric implant site preparation (PISP) has been proposed as an alternative technique to improve surgical control, safety, and bone healing response Aim of the work: To evaluate and compare stability changes using insertion torque values (ITV) and Implant Stability Quotient values (ISQ) for immediately placed implants in molar septum using Osseodensification technique and Piezoelectric implant site preparation (PISP) technique.

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
      • Alexandria, Egypt
        • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with hopeless mandibular molar teeth in the posterior region in need of implant placement .
  • A fully intact facial bone wall at the extraction site.
  • Systemically healthy, received no head and neck radiation for cancer treatment.
  • Absence of periapical pathologies or suppuration at the time of installing the implants.
  • Septal bone after atraumatic extraction not less than 3 mm.

Exclusion Criteria:

  • Systemic conditions that would prevent successful healing or implant osseointegration; examples are uncontrolled Diabetes Mellitus, metabolic bone disorders, autoimmune diseases, or Bisphosphonate therapy.
  • Heavy smoker patients.
  • Presence of preapical bone loss related to extracted tooth.
  • Patient is not indicated for immediate implant placement

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: piezoelectric group
Other: Piezotome
Four Intra-lift diamond tips were used for drilling the osteotomy, increasing diameters till a final diameter of 2.8 mm is reached for placement of 3.5 mm diameter and 10-12 mm length implant.
Experimental: osseodensification
Other: Densah burs
implant drilling procedures will be done using the surgical drills of the supplier kit of densah burs. Surgical drills of increasing diameters will be used till a final drill diameter of 3 mm for placement of a 3.5 mm diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in implant stability
Time Frame: Baseline and 3 months
The implant stability quotient (ISQ) will be measured using the Osstell device- resonance frequency analysis test at 3 months post-surgery to all the installed fixtures.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bone density
Time Frame: Baseline and 3 months
Using CBCT
Baseline and 3 months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

November 23, 2023

Primary Completion (Actual)

August 24, 2024

Study Completion (Actual)

August 24, 2024

Study Registration Dates

First Submitted

April 27, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2025

Last Update Submitted That Met QC Criteria

April 27, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 0716-06/2023

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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