JMIR Publications

Background:

Delayed placement of dental implants often leads to bone resorption, particularly in the posterior region, compromising the conditions required for successful implant placement. Osseodensification (OD), a technique using specialized rotary instruments to compact and densify bone, may improve bone quality by increasing the density and strength. This technique will be proposed to counteract bone resorption and enhance implant stability, osseointegration, and overall clinical outcomes. However, its effectiveness compared to conventional drilling methods has not been fully explored. This study determines whether OD can achieve superior clinical results, ultimately improving the success of dental implant placement.

Objective:

The objectives of this study are to assess how effectively the OD system works to increase bone volume and density at regions where implants are scheduled to be positioned later. Through clinical and radiographic analyses, the study also strives to evaluate the impact of the OD method on the main stability and osseointegration of dental implants. With an emphasis on bone healing, implant success rates, and the frequency of issues and it further seeks to compare the clinical and radiological results of implants positioned using the OD system.

Methods:

This will be a nine-month single-arm clinical and radiographic study in 22 systemically healthy patients with D2–D3 bone quality in edentulous region/s in the anterior or posterior arch. Pre-operative full-mouth ultrasonic scaling, dental hygiene instructions, and pre-operative Cone Beam Computed Tomography (CBCT) imaging will be obtained to measure the bone density at the coronal (mesial and distal), apical regions of the extraction socket in Hounsfield Units (HU). Following local anaesthesia and implant surgery, OD method will be applied to increase the density of the bone during osteotomy site preparation that eventually will help to improve the insertion torque. Simultaneously, Implant Stability Quotient (ISQ) values, which are derived from resonance frequency analysis, will be used to evaluate implant stability. Postoperative care will include antibiotics, anti-inflammatory drugs, and follow-up visits. CBCT imaging will be done at baseline, 3 months, and 9 months post-surgery. Recruitment began in July 2025 following ethics approval and trial registration (CTRI/2025/03/082513). The primary outcomes include changes in bone density and implant stability over time; secondary outcomes assess peri-implant bone healing, osseointegration, and complication rates.

Results:

Recruitment for this pilot study began in July 2025, and as of October 2025, screening and baseline assessments are ongoing. Enrolment of the target sample (n = 22) is expected to be completed by January 2026. The surgical phase, including delayed implant placement using the osseodensification (OD) technique, will be completed by Month 6 (April 2026). Clinical and radiographic follow-up evaluations, including CBCT-based bone density and implant stability (ISQ) assessments, will be performed at baseline, 3 months, and 9 months post-surgery. Final data collection and statistical analysis are anticipated by July 2026. No outcome data are yet available, as the study is currently in progress.

Conclusions:

Within the limitations of this ongoing pilot study, OD is expected to demonstrate potential improvements in bone density and implant stability in delayed implant placement. The study’s findings will provide preliminary evidence on feasibility, guide methodological refinements, and support the design of future large-scale, controlled clinical trials comparing OD with conventional osteotomy techniques.

ClinicalTrial:

Ctri/2025/03/082513

International Registered Report:

PRR1-10.2196/80200