NCT07475416

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

March 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 11, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

biological drillinglow speed drillingdental implantsimplant stabilityautogenous bone particalsBMP-2VEGFmandibular implants

Outcome Measures

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.

    At time of insertion and 3 months postoperatively.

Secondary Outcomes (1)

  • Osteogenic Potential of Autogenous Bone Particles

    Immediately after bone particle collection and subsequent laboratory analysis.

Study Arms (3)

50 rpm Biological Drilling

EXPERIMENTAL

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.

150 rpm Biological Drilling

EXPERIMENTAL

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.

300 rpm Biological Drilling

EXPERIMENTAL

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

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.

50 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.

150 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.

300 rpm Biological Drilling

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 38922797BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The investigator responsible for laboratory analysis of bone particle samples and outcome assessment will be blinded to the drilling speed group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants requiring a single mandibular dental implant will be randomly assigned to one of three drilling speed protocols during implant osteotomy. The drilling speeds include 50 rpm, 150 rpm, and 300 rpm without irrigation. Implant stability will be assessed after implant placement, and autogenous bone particles generated during osteotomy will be collected for laboratory evaluation of osteogenic potential.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

March 15, 2026

Primary Completion

March 15, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03