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Not yet recruitingNCT07474454Updated Mar 16, 2026

Mandibular Biological Drilling at Different Speeds for Dental Implant Placement

An interventional study of biological drilling at 50 RPM and biological drilling at 150 RPM in Edentulism and Tooth Loss, sponsored by Cairo University. Not yet recruiting. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Edentulism
  • Tooth Loss

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Keywords

  • dental implants
  • biological drilling
  • low speed drilling
  • marginal bone loss
  • implant stability
  • mandible
  • randomized clinical trial
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
39 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Procedurebiological drilling at 50 RPM

    Biological drilling (no irrigation) at 50 rpm for all sequential drills.

  • Procedurebiological drilling at 150 RPM

    Biological drilling (no irrigation) at 150 rpm for all sequential drills.

  • Procedurebiological drilling at 300 RPM

    Biological drilling (no irrigation) at 300 rpm for all sequential drills.

05

What researchers measure

Primary outcomes

  1. Marginal Bone Level Change

    Change in bone level measured from a fixed implant reference point to the crestal bone level using periapical radiographs.

    Time frame: Baseline (Surgery) and 12 months postoperatively.

Secondary outcomes

  1. Implant Stability

    Measured via Resonance Frequency Analysis (RFA) to obtain Implant Stability Quotient (ISQ) values.

    Time frame: At time of insertion and 3 months postoperatively.

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Abdel Motagly, M., El Khadem, A. and Abdel Rassoul, M.A. (2021) Assessment of low-speed drilling without irrigation versus conventional drilling with irrigation regarding heat generation and peri-implant marginal bone loss (randomised clinical trial). Alexandria Dental Journal, 46(2), Article 6, pp. 33-38
  • Srivastava S, Srivastava SK, Shekhar A, Chaturvedi A, Sarkar D. A Comparative Evaluation of Marginal Bone Loss Around Dental Implants Using Slow- and Medium-Speed Drilling Without Irrigation Versus High-Speed Drilling With Irrigation: An In Vivo Study. Cureus. 2025 May 24;17(5):e84730. doi: 10.7759/cureus.84730. eCollection 2025 May. PubMed 40551940 ↗
08

Registry details

Key details

Study ID
NCT07474454
Lead sponsor
Cairo University
Responsible party
Omar Emam (Dr., Cairo University) — Principal investigator
First posted
Mar 16, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Apr 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Mar 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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