Mandibular Biological Drilling at Different Speeds for Dental Implant Placement

March 11, 2026 updated by: Omar Emam, Cairo University

Radiographic Assessment of Mandibular Biological Drilling at Different Drilling Speeds: A Randomized Clinical Trial

This randomized controlled clinical trial aims to evaluate the effect of different biological drilling speeds (50, 150, and 300 rpm) during implant osteotomy preparation in the mandible on marginal bone level changes and implant stability. Thirty-nine patients requiring a single dental implant in the mandible will be randomly allocated into three groups according to drilling speed. All implants will be placed using a biological drilling protocol without irrigation. Implant stability will be measured using resonance frequency analysis at implant placement and follow-up visits. Marginal bone levels will be evaluated radiographically using standardized periapical radiographs during the follow-up period up to 12 months. The study aims to determine whether different low-speed drilling protocols influence peri-implant bone remodeling and implant stability.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized parallel-group clinical trial will investigate the influence of different biological drilling speeds on radiographic marginal bone level changes and implant stability in mandibular dental implant placement.

Thirty-nine partially edentulous adult patients requiring a single implant in the mandible will be recruited from the outpatient clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. Eligible participants will be randomly assigned to one of three groups according to drilling speed used during osteotomy preparation: 50 rpm, 150 rpm, or 300 rpm.

Implant site preparation will be performed using the same sequential drilling protocol and implant system in all groups. Biological drilling will be performed without irrigation, with careful control of drilling pressure and intermittent drilling to minimize thermal trauma.

Implant stability will be measured using resonance frequency analysis (RFA) at implant placement and during follow-up visits. Radiographic assessment of marginal bone levels will be conducted using standardized periapical radiographs obtained using the paralleling technique. Radiographic measurements will be performed at baseline and during follow-up visits up to 12 months.

The primary outcome of the study will be marginal bone level changes measured radiographically in millimeters. The secondary outcome will be implant stability expressed as Implant Stability Quotient (ISQ) values.

The results of this study may help identify the optimal biological drilling speed that preserves bone vitality while maintaining adequate implant stability and favorable peri-implant bone remodeling.

Study Type

Interventional

Enrollment (Estimated)

39

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 aged 20-60 years.
  • Partially edentulous patients requiring a single dental implant in the mandible.
  • Adequate bone height and width at the implant site to accommodate the planned implant dimensions without the need for advanced grafting.
  • Good oral hygiene (full-mouth plaque and bleeding scores within acceptable limits).
  • Patients willing to participate, available for 12-month follow-up, and able to sign informed consent.

Exclusion Criteria:

  • Systemic diseases or conditions that may compromise bone healing (e.g. uncontrolled diabetes, immunosuppression, recent radiotherapy in head and neck region).
  • Smoking more than 10 cigarettes/day or heavy vaping.
  • Pregnant or lactating women.
  • History of bisphosphonate or other anti-resorptive therapy affecting bone metabolism.
  • Active periodontal disease or poor oral hygiene.
  • Acute infection or pathology at the planned implant site.
  • Need for simultaneous major bone grafting at the same site.
  • Bruxism or severe parafunctional habits.

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: Biological drilling at 50 rpm
Participants in this group will undergo dental implant site preparation using a very low-speed "biological" drilling protocol set at 50 rpm. This arm tests the effect of maximal biologic preservation on peri-implant bone maintenance and stability.
Procedure: biological drilling at 50 RPM
Biological drilling (no irrigation) at 50 rpm for all sequential drills.
Experimental: Biological drilling at 150 rpm
Participants in this group will undergo dental implant site preparation using an intermediate low-speed protocol set at 150 rpm. This arm represents a balance between cutting efficiency and reduced thermal risk
Procedure: biological drilling at 150 RPM
Biological drilling (no irrigation) at 150 rpm for all sequential drills.
Experimental: Biological drilling at 300 rpm
Participants in this group will undergo dental implant site preparation using a higher low-speed protocol set at 300 rpm. This arm tests whether increasing speed within the "biological" range affects marginal bone remodeling
Procedure: biological drilling at 300 RPM
Biological drilling (no irrigation) at 300 rpm for all sequential drills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Bone Level Change
Time Frame: Baseline (Surgery) and 12 months postoperatively.
Change in bone level measured from a fixed implant reference point to the crestal bone level using periapical radiographs.
Baseline (Surgery) and 12 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: At time of insertion and 3 months postoperatively.
Measured via Resonance Frequency Analysis (RFA) to obtain Implant Stability Quotient (ISQ) values.
At time of insertion and 3 months postoperatively.

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)

April 1, 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 8

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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