EdentulismNCT07475416
Effect of Mandibular Drilling Speed on Implant Stability and Osteogenic Potential: A Randomized Clinical Trial
A study testing Implant osteotomy using biological drilling at 50 rpm without irrigation., Implant osteotomy using biological drilling at 150 rpm without irrigation. and Implant osteotomy using biological drilling at 300 rpm without irrigation. in people with Edentulism and Tooth Loss, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Edentulism, Tooth Loss
- What is being tested?
- Implant osteotomy using biological drilling at 50 rpm without irrigation., Implant osteotomy using biological drilling at 150 rpm without irrigation. and Implant osteotomy using biological drilling at 300 rpm without irrigation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Impact of Mandibular Biological Drilling Speeds on Implant Stability and Osteogenic Potential of Autogenous Bone Particles: A Randomized Clinical Trial
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.
- Conditions
- Edentulism, Tooth Loss
- Being tested
- Implant 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.
- Keywords
- biological drilling, low speed drilling, dental implants, implant stability, autogenous bone particals, BMP-2, VEGF, mandibular implants
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant osteotomy using biological drilling at 50 rpm without irrigation.Procedure or surgery
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 or surgery
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 or surgery
Implant osteotomy will be performed using biological drilling at 300 rpm without irrigation with collection of autogenous bone particles for laboratory analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Implant osteotomy using biological drilling at 300 rpm without irrigation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after bone particle collection and subsequent laboratory analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Amr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475416
- Sponsor's protocol ID
- OMFS 3 3 5 9
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mandibular Biological Drilling Speeds on Implant Stability and Osteogenic Potential of Autogenous Bone Particles: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07475416
- Acronym / sponsor ID
- OMFS 3 3 5 9
- Conditions
- Edentulism, Tooth Loss
- Keywords
- biological drilling, low speed drilling, dental implants, implant stability, autogenous bone particals, BMP-2, VEGF, mandibular implants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 50 rpm Biological Drilling | Experimental | Procedure: 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 Drilling | Experimental | Procedure: 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 Drilling | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Systemic diseases affecting bone metabolism or healing
- History of radiotherapy in the head and neck region
- Uncontrolled diabetes mellitus
- Active periodontal disease
- Heavy smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 50 rpm Biological Drilling |
| 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. | Procedure or surgery | 150 rpm Biological Drilling |
| 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. | Procedure or surgery | 300 rpm Biological Drilling |
Primary outcome
Implant Stability
Time frame: 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.
1 secondary outcome
Osteogenic Potential of Autogenous Bone Particles
Time frame: Immediately after bone particle collection and subsequent laboratory analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 38922797Camacho-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Implant osteotomy using biological drilling at 50 rpm without irrigation., Implant osteotomy using biological drilling at 150 rpm without irrigation. and Implant osteotomy using biological drilling at 300 rpm without irrigation. in people with Edentulism and Tooth Loss, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability (time frame: At time of insertion and 3 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07475416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.