Dental Implant Surgery, Osteotomy Protocols
Conditions
Keywords
Dental implants, Osteotomy protocols, Implant stability, Insertion torque, Resonance frequency analysis, Osseodensification, Bone condensation, Patient anxiety
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.
Interventions
PROCEDUREOsteotomy technique - CDS (Bone Condensation)
Bone condensation with condenser drills at 50 rpm clockwise without irrigation.
PROCEDUREOsteotomy technique - 50 Rpm
Ultra-low-speed sequential drilling at 50 rpm without irrigation.
PROCEDUREOsteotomy technique - 300 Rpm
Moderate-speed sequential drilling at 300 rpm with irrigation.
PROCEDUREOsteotomy technique - 800 Rpm
High-speed sequential drilling at 800 rpm with irrigation.
PROCEDUREOsteotomy technique - DNS (Osseodensification)
Osseodensification using Densah® burs at 1200 rpm counterclockwise with irrigation.
Sponsors
Sercan Küçükkurt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
A randomized, controlled, parallel-group clinical trial comparing five different implant osteotomy techniques with respect to insertion torque, implant stability, and patient-reported anxiety.
Eligibility
Sex/Gender
ALL
Age
20 Years to 78 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Torque at Implant Placement | 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. |
| Implant Stability Quotient (ISQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Anxiety (VAS) | 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. |
| Procedure-Related Adverse Events | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed