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

Sercan Küçükkurt

Status: Completed

Conditions: Osteotomy Protocols; Dental Implant Surgery

Treatments: Procedure: Osteotomy technique - DNS (Osseodensification); Procedure: Osteotomy technique - 800 Rpm; Procedure: Osteotomy technique - CDS (Bone Condensation); Procedure: Osteotomy technique - 50 Rpm; Procedure: Osteotomy technique - 300 Rpm

Study type: Interventional

Funder types: Other

Identifiers

NCT07234214

IAU-OMS-OSTEO-RCT-01

IAU Ethics Approval 2023/141 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 78 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 5 patient groups

50 rpm - Ultra-low-speed drilling

Experimental group

Description:

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

Treatment:

Procedure: Osteotomy technique - 50 Rpm

300 rpm - Moderate-speed drilling

Experimental group

Description:

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

Treatment:

Procedure: Osteotomy technique - 300 Rpm

800 Rpm - High-speed drilling

Experimental group

Description:

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

Treatment:

Procedure: Osteotomy technique - 800 Rpm

DNS - Osseodensification

Experimental group

Description:

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

Treatment:

Procedure: Osteotomy technique - DNS (Osseodensification)

CDS - Bone condensation

Experimental group

Description:

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

Treatment:

Procedure: Osteotomy technique - CDS (Bone Condensation)