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CompletedNCT07234214OSTEO-ISQUpdated Nov 18, 2025

Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety

An interventional study of Osteotomy technique - 50 Rpm and Osteotomy technique - 300 Rpm in Dental Implant Surgery and Osteotomy Protocols, sponsored by Sercan Küçükkurt. Completed at 1 site in Turkey (Türkiye). Open to participants aged 20 Years to 78 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Sercan Küçükkurt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 2 months after the study started (first participant enrolled Sep 2019, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 78 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Dental Implant Surgery
  • Osteotomy Protocols

Keywords

  • Dental implants
  • Osteotomy protocols
  • Implant stability
  • Insertion torque
  • Resonance frequency analysis
  • Osseodensification
  • Bone condensation
  • Patient anxiety
03

In context

Lead sponsor

Sercan Küçükkurt is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    50 rpm - Ultra-low-speed drilling

    Sequential osteotomy drilling at 50 rpm without irrigation, followed by implant placement.

    Procedure: Osteotomy technique - 50 Rpm

  • Experimental
    300 rpm - Moderate-speed drilling

    Sequential osteotomy drilling at 300 rpm with external irrigation, followed by implant placement.

    Procedure: Osteotomy technique - 300 Rpm

  • Experimental
    800 Rpm - High-speed drilling

    Sequential osteotomy drilling at 800 rpm with external irrigation, followed by implant placement.

    Procedure: Osteotomy technique - 800 Rpm

  • Experimental
    DNS - Osseodensification

    Osteotomy prepared with Densah® burs (Versah, USA) at 1200 rpm counterclockwise with irrigation, following pilot drilling.

    Procedure: Osteotomy technique - DNS (Osseodensification)

  • Experimental
    CDS - Bone condensation

    Osteotomy prepared with condenser drills (Surgident, South Korea) at 50 rpm clockwise without irrigation, following pilot drilling at 800 rpm.

    Procedure: Osteotomy technique - CDS (Bone Condensation)

Interventions

  • ProcedureOsteotomy technique - 50 Rpm

    Ultra-low-speed sequential drilling at 50 rpm without irrigation.

  • ProcedureOsteotomy technique - 300 Rpm

    Moderate-speed sequential drilling at 300 rpm with irrigation.

  • ProcedureOsteotomy technique - 800 Rpm

    High-speed sequential drilling at 800 rpm with irrigation.

  • ProcedureOsteotomy technique - DNS (Osseodensification)

    Osseodensification using Densah® burs at 1200 rpm counterclockwise with irrigation.

  • ProcedureOsteotomy technique - CDS (Bone Condensation)

    Bone condensation with condenser drills at 50 rpm clockwise without irrigation.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the time of implant placement.

  2. Implant Stability Quotient (ISQ)

    Implant stability measured by resonance frequency analysis (RFA) using the Osstell Mentor™ device. Mean of buccolingual and mesiodistal measurements recorded.

    Time frame: At baseline, 1 week, 1 month, 2 months, and 3 months after implant placement.

Secondary outcomes

  1. Change in Patient-Reported Anxiety (VAS)

    Visual analog scale (0-10; 0 = no fear, 10 = extreme fear). Difference between preoperative and immediate postoperative scores.

    Time frame: Preoperative (within 30 minutes before surgery) and immediate postoperative (within 30 minutes after surgery).

  2. 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.

    Time frame: From surgery to 3 months.

07

Study locations

1 site
  • Istanbul Aydın University, Faculty of Dentistry
    Istanbul, 34295, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07234214
Lead sponsor
Sercan Küçükkurt
Responsible party
Sercan Küçükkurt (Associate Professor, Istanbul Aydın University) — Sponsor-investigator
First posted
Nov 18, 2025
Start date
Sep 1, 2019
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Nov 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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