Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety (OSTEO-ISQ)

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant Surgery; Osteotomy Protocols
• Intervention / Treatment: Procedure: Osteotomy technique - 50 Rpm; Procedure: Osteotomy technique - 300 Rpm; Procedure: Osteotomy technique - 800 Rpm; Procedure: Osteotomy technique - DNS (Osseodensification); Procedure: Osteotomy technique - CDS (Bone Condensation)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 rpm - Ultra-low-speed drilling; Sequential osteotomy drilling at 50 rpm without irrigation, followed by implant placement.	Procedure: Osteotomy technique - 50 Rpm; Ultra-low-speed sequential drilling at 50 rpm without irrigation.
Experimental: 300 rpm - Moderate-speed drilling; Sequential osteotomy drilling at 300 rpm with external irrigation, followed by implant placement.	Procedure: Osteotomy technique - 300 Rpm; Moderate-speed sequential drilling at 300 rpm with irrigation.
Experimental: 800 Rpm - High-speed drilling; Sequential osteotomy drilling at 800 rpm with external irrigation, followed by implant placement.	Procedure: Osteotomy technique - 800 Rpm; High-speed sequential drilling at 800 rpm with irrigation.
Experimental: DNS - Osseodensification; Osteotomy prepared with Densah® burs (Versah, USA) at 1200 rpm counterclockwise with irrigation, following pilot drilling.	Procedure: Osteotomy technique - DNS (Osseodensification); Osseodensification using Densah® burs at 1200 rpm counterclockwise with irrigation.
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); Bone condensation with condenser drills at 50 rpm clockwise without irrigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At baseline, 1 week, 1 month, 2 months, and 3 months after implant placement.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Anxiety (VAS)	Visual analog scale (0-10; 0 = no fear, 10 = extreme fear). Difference between preoperative and immediate postoperative scores.	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.	From surgery to 3 months.

Collaborators and Investigators

• Sponsor: Sercan Küçükkurt

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Dental implants; Osseodensification; Implant stability; Resonance frequency analysis; Patient anxiety; Osteotomy protocols; Insertion torque; Bone condensation
• Other Study ID Numbers: IAU-OMS-OSTEO-RCT-01; IAU Ethics Approval 2023/141 (Other Identifier: Istanbul Aydın University Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No