NCT07234214

Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety

Comparison of Five Osteotomy Protocols on Implant Stability and Patient Anxiety: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sercan Küçükkurt · Academic / Other
• Sex: All
• Age: 20 Years – 78 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	Osteotomy technique - 50 Rpm	Ultra-low-speed sequential drilling at 50 rpm without irrigation.
PROCEDURE	Osteotomy technique - 300 Rpm	Moderate-speed sequential drilling at 300 rpm with irrigation.
PROCEDURE	Osteotomy technique - 800 Rpm	High-speed sequential drilling at 800 rpm with irrigation.
PROCEDURE	Osteotomy technique - DNS (Osseodensification)	Osseodensification using Densah® burs at 1200 rpm counterclockwise with irrigation.
PROCEDURE	Osteotomy technique - CDS (Bone Condensation)	Bone condensation with condenser drills at 50 rpm clockwise without irrigation.

Timeline

• Start date: 2019-09-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Turkey (Türkiye)