Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety

NCT ID: NCT07234214

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-05-01

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.

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

Osteotomy Protocols; Dental Implant Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

50 rpm - Ultra-low-speed drilling

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

Group Type: EXPERIMENTAL

Osteotomy technique - 50 Rpm

Intervention Type: PROCEDURE

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

300 rpm - Moderate-speed drilling

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

Group Type: EXPERIMENTAL

Osteotomy technique - 300 Rpm

Intervention Type: PROCEDURE

Moderate-speed sequential drilling at 300 rpm with irrigation.

800 Rpm - High-speed drilling

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

Group Type: EXPERIMENTAL

Osteotomy technique - 800 Rpm

Intervention Type: PROCEDURE

High-speed sequential drilling at 800 rpm with irrigation.

DNS - Osseodensification

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

Group Type: EXPERIMENTAL

Osteotomy technique - DNS (Osseodensification)

Intervention Type: PROCEDURE

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

CDS - Bone condensation

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

Group Type: EXPERIMENTAL

Osteotomy technique - CDS (Bone Condensation)

Intervention Type: PROCEDURE

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

Interventions

Osteotomy technique - 50 Rpm

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

Intervention Type: PROCEDURE

Osteotomy technique - 300 Rpm

Moderate-speed sequential drilling at 300 rpm with irrigation.

Intervention Type: PROCEDURE

Osteotomy technique - 800 Rpm

High-speed sequential drilling at 800 rpm with irrigation.

Intervention Type: PROCEDURE

Osteotomy technique - DNS (Osseodensification)

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

Intervention Type: PROCEDURE

Osteotomy technique - CDS (Bone Condensation)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sercan Küçükkurt

OTHER

Sponsor Role: lead

Responsible Party

Sercan Küçükkurt

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istanbul Aydın University, Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IAU Ethics Approval 2023/141

Identifier Type: OTHER

Identifier Source: secondary_id

IAU-OMS-OSTEO-RCT-01

Identifier Type: -

Identifier Source: org_study_id