Dental Implant SurgeryOSTEO-ISQNCT07234214
Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety
A study testing Osteotomy technique - 50 Rpm, Osteotomy technique - 300 Rpm and Osteotomy technique - 800 Rpm in people with Dental Implant Surgery and Osteotomy Protocols, run by Sercan Küçükkurt at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial is studying different methods of preparing bone for dental implants. When a tooth is missing, a small titanium screw called a dental implant can be placed in the jaw to replace it. The stability of the implant during the first weeks after surgery is very important for long-term success. Read more about this study
- Who is it for?
- Ages 20 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Surgery, Osteotomy Protocols
- What is being tested?
- Osteotomy technique - 50 Rpm, Osteotomy technique - 300 Rpm and Osteotomy technique - 800 Rpm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 20-78 years
- Single-tooth healed edentulous ridge
- First-time implant candidates
- Preoperative cone-beam computed tomography (CBCT) available
- American Society of Anesthesiologists (ASA) Physical Status I
- Non-smokers or light smokers (<10 cigarettes/day)
- Provided written informed consent
Who cannot join
- Previous grafting or sinus augmentation at the implant site, including socket grafting after extraction
- Systemic contraindications to implant surgery
- Intraoperative complications or postoperative infections
- Missing insertion torque (IT) or ISQ data
- Requirement for a submerged (two-stage) protocol
- Deviations from the standardized surgical protocol or implant system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University, Faculty of Dentistry
Istanbul, 34295
About this study
Official title: Comparison of Five Osteotomy Protocols on Implant Stability and Patient Anxiety: A Randomized Controlled Clinical Trial
This clinical trial is studying different methods of preparing bone for dental implants. When a tooth is missing, a small titanium screw called a dental implant can be placed in the jaw to replace it. The stability of the implant during the first weeks after surgery is very important for long-term success.
In this study, 100 patients each received a single dental implant. They were randomly assigned to one of five surgical methods: drilling at 50, 300, or 800 revolutions per minute (rpm), bone densification using special burs, or bone condensation using condenser drills. The goal was to compare how these techniques affect implant stability, measured by insertion torque and resonance frequency analysis, as well as the patient's anxiety before and after surgery.
This research aims to find which technique provides the best balance between bone healing and patient comfort. All participants were healthy adults, and the study was approved by the institutional ethics committee.
Read the detailed description
This prospective randomized controlled clinical trial was conducted at Istanbul Aydın University, Department of Oral and Maxillofacial Surgery, between 2019 and 2023. A total of 100 systemically healthy adults requiring a single dental implant in a healed edentulous ridge were enrolled. Patients were randomly assigned (n = 20 per group) to one of five osteotomy protocols:
Sequential drilling at 50 rpm without irrigation
Sequential drilling at 300 rpm with irrigation
Sequential drilling at 800 rpm with irrigation
Osseodensification with densifying burs at 1200 rpm (counterclockwise, irrigated)
Bone condensation using condenser drills at 50 rpm (clockwise, non-irrigated, following pilot drilling)
The same tapered titanium implant system was used in all patients. Primary outcomes were insertion torque (Ncm) and implant stability quotient (ISQ) measured at placement and at 1 week, 1 month, 2 months, and 3 months. The secondary outcome was patient-reported anxiety assessed on a visual analog scale (VAS) pre- and postoperatively.
Bone density was evaluated preoperatively using cone-beam computed tomography (CBCT, expressed as Hounsfield Unit Equivalents) and intraoperatively classified by Misch criteria. Patients with insertion torque < 25 Ncm were excluded from stability analysis and allowed to heal submerged.
The trial followed the CONSORT statement and adhered to the Declaration of Helsinki. Ethical approval was obtained (IAU 2023/141). Results are expected to clarify whether moderate-speed drilling, high-speed drilling, ultra-low-speed drilling, or non-subtractive approaches (osseodensification, condensation) provide the most favorable outcomes in terms of implant stability and patient psychological response.
- Conditions
- Dental Implant Surgery, Osteotomy Protocols
- Being tested
- Osteotomy technique - 50 Rpm, Osteotomy technique - 300 Rpm, Osteotomy technique - 800 Rpm, Osteotomy technique - DNS (Osseodensification), Osteotomy technique - CDS (Bone Condensation)
- Keywords
- Dental implants, Osteotomy protocols, Implant stability, Insertion torque, Resonance frequency analysis, Osseodensification, Bone condensation, Patient anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteotomy technique - 50 RpmProcedure or surgery
Ultra-low-speed sequential drilling at 50 rpm without irrigation.
Osteotomy technique - 300 RpmProcedure or surgery
Moderate-speed sequential drilling at 300 rpm with irrigation.
Osteotomy technique - 800 RpmProcedure or surgery
High-speed sequential drilling at 800 rpm with irrigation.
Osteotomy technique - DNS (Osseodensification)Procedure or surgery
Osseodensification using Densah® burs at 1200 rpm counterclockwise with irrigation.
Osteotomy technique - CDS (Bone Condensation)Procedure or surgery
Bone condensation with condenser drills at 50 rpm clockwise without irrigation.
| Study group | Role | What they receive |
|---|---|---|
| 50 rpm - Ultra-low-speed drilling | Experimental | Sequential osteotomy drilling at 50 rpm without irrigation, followed by implant placement. Receives: Procedure: Osteotomy technique - 50 Rpm |
| 300 rpm - Moderate-speed drilling | Experimental | Sequential osteotomy drilling at 300 rpm with external irrigation, followed by implant placement. Receives: Procedure: Osteotomy technique - 300 Rpm |
| 800 Rpm - High-speed drilling | Experimental | Sequential osteotomy drilling at 800 rpm with external irrigation, followed by implant placement. Receives: Procedure: Osteotomy technique - 800 Rpm |
| DNS - Osseodensification | Experimental | Osteotomy prepared with Densah® burs (Versah, USA) at 1200 rpm counterclockwise with irrigation, following pilot drilling. Receives: Procedure: Osteotomy technique - DNS (Osseodensification) |
| CDS - Bone condensation | Experimental | Osteotomy prepared with condenser drills (Surgident, South Korea) at 50 rpm clockwise without irrigation, following pilot drilling at 800 rpm. Receives: Procedure: Osteotomy technique - CDS (Bone Condensation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Torque at Implant Placement
Maximum insertion torque (Ncm) recorded at implant placement using a calibrated surgical motor and confirmed with a manual torque wrench when needed.
Measured: At the time of implant placement.
Implant Stability Quotient (ISQ)
Implant stability measured by resonance frequency analysis (RFA) using the Osstell Mentor™ device. Mean of buccolingual and mesiodistal measurements recorded.
Measured: At baseline, 1 week, 1 month, 2 months, and 3 months after implant placement.
Secondary outcomes (2)
Change in Patient-Reported Anxiety (VAS)
Visual analog scale (0-10; 0 = no fear, 10 = extreme fear). Difference between preoperative and immediate postoperative scores.
Measured: Preoperative (within 30 minutes before surgery) and immediate postoperative (within 30 minutes after surgery).
Procedure-Related Adverse Events
Number of participants with any procedure-related adverse event (e.g., postoperative infection, sensory disturbance, early implant failure requiring removal, wound dehiscence). Events assessed clinically and recorded at each visit.
Measured: From surgery to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Sep 2019
- Primary completion1 May 2023
- Study completion1 May 2023
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 Dental Implant SurgeryStudies of the same condition, open and under way.
- 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
- A randomized, controlled, parallel-group clinical trial comparing five different implant osteotomy techniques with respect to insertion torque, implant stability, and patient-reported anxiety.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sercan Küçükkurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sercan Küçükkurt, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234214
- Sponsor's protocol ID
- IAU-OMS-OSTEO-RCT-01
- Other IDs
- IAU Ethics Approval 2023/141
- Acronym
- OSTEO-ISQ
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konuklu R, Kucukkurt S. Comparison of Five Osteotomy Protocols on Implant Stability and Postoperative Anxiety: A Randomized Controlled Trial. Clin Implant Dent Relat Res. 2026 Feb;28(1):e70125. doi: 10.1111/cid.70125.
PubMed 41664595
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Five Osteotomy Protocols on Implant Stability and Patient Anxiety: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07234214
- Acronym / sponsor ID
- OSTEO-ISQ / IAU-OMS-OSTEO-RCT-01
- Conditions
- Dental Implant Surgery, Osteotomy Protocols
- Keywords
- Dental implants, Osteotomy protocols, Implant stability, Insertion torque, Resonance frequency analysis, Osseodensification, Bone condensation, Patient anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sercan KüçükkurtUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 18 Nov 2025 (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 clinical trial is studying different methods of preparing bone for dental implants. When a tooth is missing, a small titanium screw called a dental implant can be placed in the jaw to replace it. The stability of the implant during the first weeks after surgery is very important for long-term success.
In this study, 100 patients each received a single dental implant. They were randomly assigned to one of five surgical methods: drilling at 50, 300, or 800 revolutions per minute (rpm), bone densification using special burs, or bone condensation using condenser drills. The goal was to compare how these techniques affect implant stability, measured by insertion torque and resonance frequency analysis, as well as the patient's anxiety before and after surgery.
This research aims to find which technique provides the best balance between bone healing and patient comfort. All participants were healthy adults, and the study was approved by the institutional ethics committee.
Detailed description
This prospective randomized controlled clinical trial was conducted at Istanbul Aydın University, Department of Oral and Maxillofacial Surgery, between 2019 and 2023. A total of 100 systemically healthy adults requiring a single dental implant in a healed edentulous ridge were enrolled. Patients were randomly assigned (n = 20 per group) to one of five osteotomy protocols:
Sequential drilling at 50 rpm without irrigation
Sequential drilling at 300 rpm with irrigation
Sequential drilling at 800 rpm with irrigation
Osseodensification with densifying burs at 1200 rpm (counterclockwise, irrigated)
Bone condensation using condenser drills at 50 rpm (clockwise, non-irrigated, following pilot drilling)
The same tapered titanium implant system was used in all patients. Primary outcomes were insertion torque (Ncm) and implant stability quotient (ISQ) measured at placement and at 1 week, 1 month, 2 months, and 3 months. The secondary outcome was patient-reported anxiety assessed on a visual analog scale (VAS) pre- and postoperatively.
Bone density was evaluated preoperatively using cone-beam computed tomography (CBCT, expressed as Hounsfield Unit Equivalents) and intraoperatively classified by Misch criteria. Patients with insertion torque < 25 Ncm were excluded from stability analysis and allowed to heal submerged.
The trial followed the CONSORT statement and adhered to the Declaration of Helsinki. Ethical approval was obtained (IAU 2023/141). Results are expected to clarify whether moderate-speed drilling, high-speed drilling, ultra-low-speed drilling, or non-subtractive approaches (osseodensification, condensation) provide the most favorable outcomes in terms of implant stability and patient psychological response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A randomized, controlled, parallel-group clinical trial comparing five different implant osteotomy techniques with respect to insertion torque, implant stability, and patient-reported anxiety.
| Arm | Type | Receives |
|---|---|---|
| 50 rpm - Ultra-low-speed drilling | Experimental | Procedure: Osteotomy technique - 50 RpmSequential osteotomy drilling at 50 rpm without irrigation, followed by implant placement. |
| 300 rpm - Moderate-speed drilling | Experimental | Procedure: Osteotomy technique - 300 RpmSequential osteotomy drilling at 300 rpm with external irrigation, followed by implant placement. |
| 800 Rpm - High-speed drilling | Experimental | Procedure: Osteotomy technique - 800 RpmSequential osteotomy drilling at 800 rpm with external irrigation, followed by implant placement. |
| DNS - Osseodensification | Experimental | Procedure: Osteotomy technique - DNS (Osseodensification)Osteotomy prepared with Densah® burs (Versah, USA) at 1200 rpm counterclockwise with irrigation, following pilot drilling. |
| CDS - Bone condensation | Experimental | Procedure: Osteotomy technique - CDS (Bone Condensation)Osteotomy prepared with condenser drills (Surgident, South Korea) at 50 rpm clockwise without irrigation, following pilot drilling at 800 rpm. |
Who may qualify
- Ages
- 20 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 20-78 years
- Single-tooth healed edentulous ridge
- First-time implant candidates
- Preoperative cone-beam computed tomography (CBCT) available
- American Society of Anesthesiologists (ASA) Physical Status I
Key exclusion criteria (6 listed)
- Previous grafting or sinus augmentation at the implant site, including socket grafting after extraction
- Systemic contraindications to implant surgery
- Intraoperative complications or postoperative infections
- Missing insertion torque (IT) or ISQ data
- Requirement for a submerged (two-stage) protocol
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 |
|---|---|---|
| Osteotomy technique - 50 RpmUltra-low-speed sequential drilling at 50 rpm without irrigation. | Procedure or surgery | 50 rpm - Ultra-low-speed drilling |
| Osteotomy technique - 300 RpmModerate-speed sequential drilling at 300 rpm with irrigation. | Procedure or surgery | 300 rpm - Moderate-speed drilling |
| Osteotomy technique - 800 RpmHigh-speed sequential drilling at 800 rpm with irrigation. | Procedure or surgery | 800 Rpm - High-speed drilling |
| Osteotomy technique - DNS (Osseodensification)Osseodensification using Densah® burs at 1200 rpm counterclockwise with irrigation. | Procedure or surgery | DNS - Osseodensification |
| Osteotomy technique - CDS (Bone Condensation)Bone condensation with condenser drills at 50 rpm clockwise without irrigation. | Procedure or surgery | CDS - Bone condensation |
Primary outcome
Insertion Torque at Implant Placement
Time frame: At the time of implant placement.
Maximum insertion torque (Ncm) recorded at implant placement using a calibrated surgical motor and confirmed with a manual torque wrench when needed.
Implant Stability Quotient (ISQ)
Time frame: At baseline, 1 week, 1 month, 2 months, and 3 months after implant placement.
Implant stability measured by resonance frequency analysis (RFA) using the Osstell Mentor™ device. Mean of buccolingual and mesiodistal measurements recorded.
2 secondary outcomes
Change in Patient-Reported Anxiety (VAS)
Time frame: Preoperative (within 30 minutes before surgery) and immediate postoperative (within 30 minutes after surgery).
Procedure-Related Adverse Events
Time frame: From surgery to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 41664595Konuklu R, Kucukkurt S. Comparison of Five Osteotomy Protocols on Implant Stability and Postoperative Anxiety: A Randomized Controlled Trial. Clin Implant Dent Relat Res. 2026 Feb;28(1):e70125. doi: 10.1111/cid.70125.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteotomy technique - 50 Rpm, Osteotomy technique - 300 Rpm and Osteotomy technique - 800 Rpm in people with Dental Implant Surgery and Osteotomy Protocols, run by Sercan Küçükkurt at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insertion Torque at Implant Placement (time frame: At the time of implant placement.). The study lists 2 primary outcomes in all. 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 NCT07234214, 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 18 Nov 2025.