Osseodensification Versus Conventional Drilling for Implant Site Preparation

April 21, 2025 updated by: Maanas Shah, Mohammed Bin Rashid University of Medicine and Health Sciences

Osseodensification Versus Conventional Drilling for Implant Site Preparation: a Randomized Controlled Trial

A total of 34 participants, who require replacement of an anterior or posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the control group, the osteotomy site preparation will be prepared by using conventional surgical drills, while the test group site preparation will involve the use of Densah™ Burs (Versah Co., LLC., USA) as per the osseodensification protocol. In addition to evaluating implant stability, the trial will also report on implant and patient outcomes at various time points.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Osseodensification technique has demonstrated increased primary stability and increased bone mineral density around the osteotomy site. The implants placed into osseous densification osteotomies have shown significant increase in insertion and removal torque values. This technique also burnishes bone along the inner layer of the osteotomy site and create a condensed layer of autografted bone along the periphery and apex of the implant. This would, in turn, increase the bone-implant contact enhancing the insertion torque values, and thus, primary implant stability. This new technique has not only shown increased primary implant stability when compared with conventional drilling, but also, shown to have similar clinical safety to conventional methods of osteotomy site preparation. Although osseodensification has been reported to enhance the clinical outcomes of implants by increasing primary stability, its long-term effects on implant stability measurements and implant survival rates are still not clear. The purpose of the present randomized controlled trial is to evaluate the stability of implants placed in sites prepared with either conventional drilling or osseodensification and report on implant and patient outcomes at various time points.

Objectives:

The aims of the randomized controlled trial are:

  • To evaluate implant stability as measured by implant stability quotient (ISQ).
  • To evaluate the clinical, radiographic outcomes and implant survival rates.
  • To evaluate the need for additional bone augmentation at the time of implant placement.
  • To evaluate changes in peri-implant marginal bone level.
  • To evaluate bone quality as estimated by clinicians during osteotomy preparation.
  • To evaluate biological and technical complications during the follow-up period.
  • To evaluate patient reported outcomes.

Study Type

Interventional

Enrollment (Actual)

34

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

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:

  • Aged 18 or over.
  • Require replacement of an anterior or posterior single tooth with dental implant.
  • Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
  • Good compliance and commitment to attend follow-up review appointments.
  • Willing to provide informed consent.

Exclusion Criteria:

  • Localized / generalized periodontitis.
  • Bone metabolic disease and/or taking medications that affect bone metabolism.
  • Long term use of non-steroidal anti-inflammatory medications.
  • History of malignancy, radiotherapy or chemotherapy.
  • Pregnant or lactating women.
  • Severe bruxism or parafunctional habits.
  • Participants, who have controlled medical condition or smokers, will not be excluded in this study

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: Osseodensification (test) group
Implant site preparation will be completed using osseodensification technique where tapered multifluted burs (Densah Burs; Versah, MI, USA) will be used as per manufacturer's instructions.
Procedure: Osseodensification osteotomy preparation
The implant site will be prepared by raising a mucoperiosteal flap. Implant osteotomy will be prepared by using osseodensification technique using Versah burs and a dental implant will be placed. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.
Other Names:
  • Densah® burs, Versah co., USA
Active Comparator: Standard (control) group
Implant site preparation will be completed using conventional drilling protocol technique where standardized drills provided by Straumann (Straumann®, Institute Straumann AG, Basel, Switzerland)) will be used as per manufacturer's instructions.
Procedure: Standardized osteotomy preparation
The implant site will be prepared by raising a mucoperiosteal flap. Implant osteotomy will be prepared by using either conventional surgical drills provided by Straumann implant systems and a dental implant will be placed. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.
Other Names:
  • Straumann® Twist Drills, Straumann, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Implant stability quotient (ISQ values) using resonance frequency analysis
Time Frame: Upto 36 months
Resonance frequency analysis (RFA) will be used to determine stability (the level of osseointegration) in dental implants. The stability will be presented as an implant stability quotient (ISQ) value. The measurements will be recorded at time of implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using resonance frequency analysis.
Upto 36 months
Implant failure rate
Time Frame: Upto 36 months
Implant failure rate will be assessed clinically after one year of implant restoration and annually up to three years.
Upto 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in peri-implant marginal bone level (in mm)
Time Frame: Upto 36 months
Changes in peri-implant marginal bone level will be assessed at implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using standardized peri-apical radiograph. The changes in peri-implant marginal bone levels will be recorded in millimeters
Upto 36 months
Descriptive evaluation of biological and technical complications associated with dental implant restorations
Time Frame: Upto 36 months
Descriptive evaluation of biological and technical complications will be recorded during the follow-up period
Upto 36 months
Patient postoperative experience ( visual analogue scale )
Time Frame: Upto 10 days
Patient postoperative experience will be assessed using visual analogue scale during the first week following implant placement; the scale consists of a 10cm line, with end points representing 0 ('no pain') and 10 ('unbearable/worst pain'). The participant will be asked to place a mark on he line indicating the level of pain that he/she experienced.
Upto 10 days

Collaborators and Investigators

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

Sponsor

Mohammed Bin Rashid University of Medicine and Health Sciences

Investigators

  • Principal Investigator: Maanas S Shah, BDS MSD CAGS, Mohammed Bin Rashid University of Medicine and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 31, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

September 10, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBRU IRB-2021-61

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

product manufactured in and exported from the U.S.

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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