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

NCT07475416 — Not applicable, Not yet recruiting, 36 participants, Cairo University

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

RegistryNCT07475416
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment36 (Estimated)
SponsorCairo University (Other)
ConditionsEdentulism, Tooth Loss
InterventionsImplant osteotomy using biological drilling at 50 rpm without irrigation., Implant osteotomy using biological drilling at 150 rpm without irrigation., Implant osteotomy using biological drilling at 300 rpm without irrigation. (Procedure)
Datesstart 2026-03-15 (estimated), primary completion 2026-03-15 (estimated), completion 2027-04-01 (estimated), first posted 2026-03-16, last updated 2026-03-16

Related Papers Related Patents Related Grants Related Experts
All trials for Edentulism All trials for Tooth Loss All trials of Implant osteotomy using biological drilling at 50 rpm without irrigation. All trials of Implant osteotomy using biological drilling at 150 rpm without irrigation.

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
50 rpm Biological DrillingExperimentalProcedure: 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.
150 rpm Biological DrillingExperimentalProcedure: 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.
300 rpm Biological DrillingExperimentalProcedure: 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.
  • Implant osteotomy using biological drilling at 50 rpm without irrigation. (Procedure): 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.
  • Implant osteotomy using biological drilling at 150 rpm without irrigation. (Procedure): 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.
  • Implant osteotomy using biological drilling at 300 rpm without irrigation. (Procedure): Implant osteotomy will be performed using biological drilling at 300 rpm without irrigation with collection of autogenous bone particles for laboratory analysis.

+Outcome measures

Primary outcomes

  • Implant Stability [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.

Secondary outcomes

  • Osteogenic Potential of Autogenous Bone Particles [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.

+Eligibility

Sex: All, ages: 20 Years to 60 Years

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

+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. PMID 38922797