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Completed

NCT Number: NCT04741594

Osseodensification and Implant Survival and Success

Approximately 40 implants from patients seeking treatment at the University of Oklahoma, College of Dentistry will be recruited for this study. Osteotomies will be prepared using the osseodensification technique and implants will be placed immediately after. The implants will be from a single manufacturer (Roxolid® SLA® Bone Level Tapered; Straumann®, Institut Straumann AG, Basel, Switzerland). Volumetric analysis of alveolar ridge will be studied using intra-surgical direct measurements and CBCT imaging. A custom stent will be fabricated to standardize the clinical and radiographic measurements at 2mm, 3mm, and 4mm apical to the alveolar crest. Changes in peri-implant bone density will be analyzed on standardized periapical and bitewing radiographs, using the ImageJ software (National Institute of Health, Bethesda, Maryland, USA). Implant stability quotient (ISQ) values will be recorded with a resonance frequency analysis system (Osstell®, Gothenburg, Sweden). Calibrated examiners will assess implant survival and biological or restorative complications and failures. Sites will be evaluated throughout osseointegration and one year after final restoration is delivered.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, OUHSC

Oklahoma City, Oklahoma, 73117, United States

About this study

The purpose of this study was to determine the efficacy for alveolar ridge expansion and change in peri-implant density when prepared by the osseodensification technique. The retention of this volume throughout osseointegration and loading were evaluated. The changes in bone volume were recorded by CBCT and intra-surgical direct measurements. A standardizing stent was used for the CBCT and direct measurements with a caliper. CBCT was taken before and after osseodensification, and 1 year after delivery of final restoration. Standardized periapical and bitewing radiographs were also taken to evaluate marginal bone loss and peri-implant bone density. Calibrated examiners evaluated implant survival and failure rate, ISQ value, peri-implant pocket depth, plaque index, bleeding index, gingival index, biological and restorative complications.

Who can participate

Healthy volunteers accepted: Yes

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

  • Inclusion / Exclusion Criteria

The inclusion criteria include:

  • Adult patients ≥18 years old
  • Able to understand and sign a written informed consent form and willing to fulfil all study requirements
  • Healed edentulous ridge that is planned for an implant restoration.
  • Experimental site has not been previously augmented with xenograft
  • Experimental site has at least 2 mm of cancellous bone

The exclusion criteria include:

  • Uncontrolled systemic disease
  • Currently smoking >10 cigarettes/day
  • History of head/neck radiotherapy within the past five years
  • Current use of oral bisphosphonates or history of IV bisphosphonate use
  • Pregnant, expecting to become pregnant, or lactating women
  • Presence of active periodontal disease
  • Poor oral hygiene
  • Previous history of implant failure at the site

The early termination criteria include:

  • The researcher believes that it is not in the patient's best interest to stay in the study
  • Based on the exclusion criteria, the patient becomes ineligible to participate
  • Patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
  • Patient does not follow study related instructions
  • The study is suspended or canceled

Treatment and study plan

Densah

Device

Alveolar bone remodeling after tooth extraction may result in significant ridge resorption and inadequate bone volume for implant placement. Several methods have been designed for ridge augmentation, among which is the new technique of osseodensification, using the Densah® burs by Versah® (Versah®, LLC, Jackson, MI, USA). This method compresses the trabecular bone to periphery of the osteotomy site and has shown up to 80% ridge expansion in animal histological studies. Apart from being an animal model with a short follow-up, another limitation of these studies is the lack of three-dimensional evaluation of the change in morphology of the ridge. Human clinical studies have reported similar results, but they do not evaluate if this bone volume is retained during osseointegration and loading periods. No standardization method or long-term evaluation of peri-implant health was reported.

Primary outcomes

  1. Bone Width (mm)

    Time frame: Measurements were taken at baseline and 3 months after implant placement.

    Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge. Not all measurements were able to be performed on each site due to anatomic limitations per site. Results were reported at 2 mm below the alveolar crest and 4 mm below the alveolar crest, when applicable. Measurements were performed by caliper measurements during the procedure and by CBCT followup approximately 3 months after implant placement

Secondary outcomes

  1. Change in Implant Stability

    Time frame: From Initial Placement to 3 month follow-up - approximately 3 months

    Implant stability quotient (ISQ) values were performed at the time of implant placement and at the 3-month follow-up appointment, if possible. Osstell uses Resonance Frequency Analysis to determine implant stability. The result is presented as an ISQ (Implant Stability Quotient) value of 1-100. The higher the ISQ, the more stable the implant. Measure at implant placement for a baseline reading and again before final restoration.

  2. Number of Implants That Survived

    Time frame: The extent of the study was approximately 3 months after implant placement. There is some small variability in the time frame for each implant placed based on scheduling of each patient.

    This outcome measure emphasizes the number of implants in this study that have survived for analysis.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Jun 25, 2026

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.

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