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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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