Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety

NCT07234214 | Completed

• 2 other identifiers: IAU-OMS-OSTEO-RCT-01IAU Ethics Approval 2023/141
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implant Surgery; Osteotomy Protocols

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Patient-Reported Anxiety (VAS)

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

• Procedure-Related Adverse Events

  From surgery to 3 months.

Study Arms (5)

50 rpm - Ultra-low-speed drilling

EXPERIMENTAL

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

Procedure: Osteotomy technique - 50 Rpm

300 rpm - Moderate-speed drilling

EXPERIMENTAL

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

Procedure: Osteotomy technique - 300 Rpm

800 Rpm - High-speed drilling

EXPERIMENTAL

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

Procedure: Osteotomy technique - 800 Rpm

DNS - Osseodensification

EXPERIMENTAL

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

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.

Procedure: Osteotomy technique - CDS (Bone Condensation)

Interventions

Osteotomy technique - 50 Rpm PROCEDURE

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

50 rpm - Ultra-low-speed drilling

Osteotomy technique - 300 Rpm PROCEDURE

Moderate-speed sequential drilling at 300 rpm with irrigation.

300 rpm - Moderate-speed drilling

Osteotomy technique - 800 Rpm PROCEDURE

High-speed sequential drilling at 800 rpm with irrigation.

800 Rpm - High-speed drilling

Osteotomy technique - DNS (Osseodensification) PROCEDURE

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

DNS - Osseodensification

Osteotomy technique - CDS (Bone Condensation) PROCEDURE

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

CDS - Bone condensation

Eligibility Criteria

• Age: 20 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sercan Küçükkurt: lead

Study Sites (1)

Istanbul Aydın University, Faculty of Dentistry

Istanbul, 34295, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeon could not be blinded due to the nature of the interventions. However, implant stability was measured by an independent assessor, and statistical analyses were performed by a blinded biostatistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized, controlled, parallel-group clinical trial comparing five different implant osteotomy techniques with respect to insertion torque, implant stability, and patient-reported anxiety.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: September 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)