Effect of Mandibular Drilling Speed on Implant Stability and Osteogenic Potential: A Randomized Clinical Trial

March 11, 2026 updated by: Radwa Amr, Cairo University

Impact of Mandibular Biological Drilling Speeds on Implant Stability and Osteogenic Potential of Autogenous Bone Particles: A Randomized Clinical Trial

This randomized clinical trial aims to evaluate the effect of different low-speed biological drilling protocols on implant stability and the osteogenic potential of autogenous bone particles collected during implant osteotomy. Patients requiring single dental implant placement in the mandible will be randomly assigned to different drilling speed protocols without irrigation. Implant stability will be measured clinically, while collected bone particles will be analyzed for osteogenic markers. The study aims to determine whether biological drilling improves implant stability and preserves the regenerative potential of autogenous bone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary implant stability and the biological quality of bone particles generated during osteotomy are important determinants of successful osseointegration. Conventional implant site preparation typically uses high-speed drilling with irrigation to prevent thermal injury; however, this technique may compromise the biological quality and viability of harvested bone particles.

Low-speed biological drilling without irrigation has been proposed as an alternative technique that may preserve bone vitality, reduce thermal trauma, and allow collection of viable autogenous bone particles with regenerative potential.

This randomized clinical trial evaluates the influence of different mandibular drilling speeds (50 rpm, 150 rpm, and 300 rpm) during implant osteotomy on implant stability and on the osteogenic potential of the collected autogenous bone particles.

Implant stability will be assessed clinically, while the osteogenic potential of harvested bone particles will be evaluated using molecular biomarkers related to osteogenesis. The results of this study may provide evidence-based guidance for optimizing implant drilling protocols and improving bone regeneration potential in implant dentistry.

Study Type

Interventional

Enrollment (Estimated)

36

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult patients requiring single dental implant placement in the mandible

Adequate bone volume for implant placement without need for bone grafting

Good general health

Ability to provide informed consent

Exclusion Criteria:

Systemic diseases affecting bone metabolism or healing

History of radiotherapy in the head and neck region

Uncontrolled diabetes mellitus

Active periodontal disease

Heavy smoking

Pregnancy or lactation

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: 50 rpm Biological Drilling
Implant osteotomy will be performed using low-speed biological drilling at 50 rpm without irrigation. Bone particles produced during drilling will be collected for evaluation of osteogenic potential.
Procedure: Implant osteotomy using biological drilling at 50 rpm without irrigation.
Implant osteotomy will be performed using low-speed biological drilling at 50 rpm without irrigation. Bone particles produced during drilling will be collected for evaluation of osteogenic potential.
Experimental: 150 rpm Biological Drilling
Implant osteotomy will be performed using biological drilling at 150 rpm without irrigation. Autogenous bone particles generated during drilling will be collected and analyzed for osteogenic potential.
Procedure: Implant osteotomy using biological drilling at 150 rpm without irrigation.
Implant osteotomy will be performed using biological drilling at 150 rpm without irrigation. Autogenous bone particles generated during drilling will be collected and analyzed for osteogenic potential.
Experimental: 300 rpm Biological Drilling
Implant osteotomy will be performed using biological drilling at 300 rpm without irrigation with collection of autogenous bone particles for laboratory analysis.
Procedure: Implant osteotomy using biological drilling at 300 rpm without irrigation.
Implant osteotomy will be performed using biological drilling at 300 rpm without irrigation with collection of autogenous bone particles for laboratory analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: At time of insertion and 3 months postoperatively.
Implant stability will be measured immediately after implant placement and 3 months postoperatively, using resonance frequency analysis (RFA). Implant stability will be recorded as an Implant Stability Quotient (ISQ) value to evaluate the mechanical stability of the implant in relation to the drilling speed used during osteotomy.
At time of insertion and 3 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteogenic Potential of Autogenous Bone Particles
Time Frame: Immediately after bone particle collection and subsequent laboratory analysis.
Autogenous bone particles generated during implant osteotomy will be collected and analyzed for osteogenic biomarkers associated with bone formation and regeneration. Laboratory analysis will include molecular assessment of osteogenic markers using ELISA and PCR techniques.
Immediately after bone particle collection and subsequent laboratory analysis.

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFS 3 3 5 9

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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