EdentulismNCT07474454
Mandibular Biological Drilling at Different Speeds for Dental Implant Placement
A study testing biological drilling at 50 RPM, biological drilling at 150 RPM and biological drilling at 300 RPM in people with Edentulism and Tooth Loss, run by Cairo University.
Trial 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. 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?
- biological drilling at 50 RPM, biological drilling at 150 RPM and biological drilling at 300 RPM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 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 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.
Who cannot join
- 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.
About this study
Official title: Radiographic Assessment of Mandibular Biological Drilling at Different Drilling Speeds: A Randomized Clinical Trial
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.
- Conditions
- Edentulism, Tooth Loss
- Being tested
- biological drilling at 50 RPM, biological drilling at 150 RPM, biological drilling at 300 RPM
- Keywords
- dental implants, biological drilling, low speed drilling, marginal bone loss, implant stability, mandible, randomized clinical trial
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological drilling at 50 RPMProcedure or surgery
Biological drilling (no irrigation) at 50 rpm for all sequential drills.
biological drilling at 150 RPMProcedure or surgery
Biological drilling (no irrigation) at 150 rpm for all sequential drills.
biological drilling at 300 RPMProcedure or surgery
Biological drilling (no irrigation) at 300 rpm for all sequential drills.
| Study group | Role | What they receive |
|---|---|---|
| Biological drilling at 50 rpm | Experimental | 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. Receives: Procedure: biological drilling at 50 RPM |
| Biological drilling at 150 rpm | Experimental | 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 Receives: Procedure: biological drilling at 150 RPM |
| Biological drilling at 300 rpm | Experimental | 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 Receives: Procedure: biological drilling at 300 RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level Change
Change in bone level measured from a fixed implant reference point to the crestal bone level using periapical radiographs.
Measured: Baseline (Surgery) and 12 months postoperatively.
Secondary outcomes (1)
Implant Stability
Measured via Resonance Frequency Analysis (RFA) to obtain Implant Stability Quotient (ISQ) values.
Measured: At time of insertion and 3 months postoperatively.
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 completion1 Apr 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 (2)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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Emam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474454
- Sponsor's protocol ID
- OMFS 3 3 5 8
- 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
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
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
- Radiographic Assessment of Mandibular Biological Drilling at Different Drilling Speeds: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07474454
- Acronym / sponsor ID
- OMFS 3 3 5 8
- Conditions
- Edentulism, Tooth Loss
- Keywords
- dental implants, biological drilling, low speed drilling, marginal bone loss, implant stability, mandible, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 1 Apr 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biological drilling at 50 rpm | Experimental | Procedure: biological drilling at 50 RPMParticipants 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. |
| Biological drilling at 150 rpm | Experimental | Procedure: biological drilling at 150 RPMParticipants 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 |
| Biological drilling at 300 rpm | Experimental | Procedure: biological drilling at 300 RPMParticipants 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| biological drilling at 50 RPMBiological drilling (no irrigation) at 50 rpm for all sequential drills. | Procedure or surgery | Biological drilling at 50 rpm |
| biological drilling at 150 RPMBiological drilling (no irrigation) at 150 rpm for all sequential drills. | Procedure or surgery | Biological drilling at 150 rpm |
| biological drilling at 300 RPMBiological drilling (no irrigation) at 300 rpm for all sequential drills. | Procedure or surgery | Biological drilling at 300 rpm |
Primary outcome
Marginal Bone Level Change
Time frame: Baseline (Surgery) and 12 months postoperatively.
Change in bone level measured from a fixed implant reference point to the crestal bone level using periapical radiographs.
1 secondary outcome
Implant Stability
Time frame: At time of insertion and 3 months postoperatively.
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.
- BackgroundAbdel 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
- Background: PubMed 40551940Srivastava 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.
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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 biological drilling at 50 RPM, biological drilling at 150 RPM and biological drilling at 300 RPM 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 5 inclusion and 8 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?
Marginal Bone Level Change (time frame: Baseline (Surgery) and 12 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 NCT07474454, which also lists 2 linked publications.
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.