Skip to main content
OpenTrials
Completed

NCT Number: NCT07234214

Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Implant Surgery Osteotomy Protocols

Age range

20 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University, Faculty of Dentistry

Istanbul, 34295, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteotomy technique - 50 Rpm

Procedure

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

Osteotomy technique - 300 Rpm

Procedure

Moderate-speed sequential drilling at 300 rpm with irrigation.

Osteotomy technique - 800 Rpm

Procedure

High-speed sequential drilling at 800 rpm with irrigation.

Osteotomy technique - DNS (Osseodensification)

Procedure

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

Osteotomy technique - CDS (Bone Condensation)

Procedure

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

Primary outcomes

  1. Insertion Torque at Implant Placement

    Time frame: At the time of implant placement.

    Maximum insertion torque (Ncm) recorded at implant placement using a calibrated surgical motor and confirmed with a manual torque wrench when needed.

  2. Implant Stability Quotient (ISQ)

    Time frame: At baseline, 1 week, 1 month, 2 months, and 3 months after implant placement.

    Implant stability measured by resonance frequency analysis (RFA) using the Osstell Mentor™ device. Mean of buccolingual and mesiodistal measurements recorded.

Secondary outcomes

  1. Change in Patient-Reported Anxiety (VAS)

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

    Visual analog scale (0-10; 0 = no fear, 10 = extreme fear). Difference between preoperative and immediate postoperative scores.

  2. Procedure-Related Adverse Events

    Time frame: From surgery to 3 months.

    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.

Sponsors and collaborators

Lead sponsor

Sercan Küçükkurt

Other

Registry information

Official study title

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

Acronym: OSTEO-ISQ

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.