Evaluation of the Effectiveness of an Osseodensification System for Improvement in Bone Density After Delayed Implant Placement: Protocol for a Single-Arm Pilot Study.

Authors

Rutuja Karamore, Prasad Dhadse, Ruchita Patil, Sanehi Punse

Published in

JMIR research protocols. Volume 15. Pages e80200. Sep 01, 2026. Epub Sep 01, 2026.

Abstract

Delayed placement of dental implants often leads to bone resorption, particularly in the posterior region, compromising implant placement. Osseodensification uses specialized rotary instruments to compact and densify bone and may improve bone quality and implant stability. However, its effectiveness in delayed implant placement has not been fully explored.
This study aims to assess the effectiveness of osseodensification in increasing bone volume and density at regions scheduled for delayed implant placement and to evaluate its effect on implant stability and osseointegration.
This 9-month single-arm clinical and radiographic study will include 22 systemically healthy patients with D2-D3 bone quality in an edentulous region of the anterior or posterior arch. Preoperative full-mouth ultrasonic scaling, dental hygiene instructions, and cone beam computed tomography (CBCT) imaging will be performed. Bone density will be measured at the coronal (mesial and distal), middle and apical regions of the extraction socket in Hounsfield Units (MU). During implant placement, osseodensification will be used for osteotomy preparation. Implant Stability Quotient (ISQ) values will be assessed using resonance frequency analysis. 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; secondary outcomes assess peri-implant bone healing, osseointegration, and complications.
Recruitment began in July 2025, and as of October 2025, screening and baseline assessments are ongoing. Enrolment of 22 participants was expected by January 2026, with the surgical phase expected to be completed by April 2026. Follow-up evaluations 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 because the study is ongoing.
This ongoing pilot study will provide preliminary evidence on the feasibility of osseodensification for delayed implant placement and its effect on bone density and implant stability. The findings may guide methodological refinements and future controlled clinical trials.
Clinical Trials Registry India CTRI/2025/03/082513; https://tinyurl.com/34562c7b.
PRR1-10.2196/80200.

PMID:
42679351
Bibliographic data and abstract were imported from PubMed on 02 Sep 2026.

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