ClinicalTrials.gg
Not yet recruitingNCT07475416Updated Mar 16, 2026

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

An interventional study of Implant osteotomy using biological drilling at 50 rpm without irrigation. and Implant osteotomy using biological drilling at 150 rpm without irrigation. 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

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Edentulism
  • Tooth Loss

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Keywords

  • biological drilling
  • low speed drilling
  • dental implants
  • implant stability
  • autogenous bone particals
  • BMP-2
  • VEGF
  • mandibular implants
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 36 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • 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.

  • 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.

  • 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.

Interventions

  • ProcedureImplant 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.

  • ProcedureImplant 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.

  • ProcedureImplant 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.

06

What researchers measure

Primary outcomes

  1. Implant Stability

    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.

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

Secondary outcomes

  1. Osteogenic Potential of Autogenous Bone Particles

    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.

    Time frame: Immediately after bone particle collection and subsequent laboratory analysis.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Camacho-Alonso F, Mercado-Diaz AM, Rivas-Ballester R, Bernabeu-Mira JC, Penarrocha-Oltra D, Del Rosario Tudela-Mulero M. Randomized split-mouth clinical trial comparing osteoblastic activity and osteogenic potential of autogenous particle harvesting during implant surgery without irrigation and with irrigation. Clin Implant Dent Relat Res. 2024 Aug;26(4):795-808. doi: 10.1111/cid.13355. Epub 2024 Jun 23. PubMed 38922797 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Mar 2026, 0 months later.

Of 71 non-industry interventional studies with no phase under Tooth Loss, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 0 months is below that.

Counting every sponsor, half of 77 studies reached it within 28 months; a quarter within 12 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2026
First posted
Mar 16, 2026
StartEst.
Mar 15, 2026
Primary completionEst.
Mar 15, 2026
CompletionEst.
Apr 1, 2027
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07475416
Lead sponsor
Cairo University
Responsible party
Radwa Amr (Dr, Cairo University) — Principal investigator
First posted
Mar 16, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Mar 15, 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 ↗

Not currently enrolling

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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