Osseodensification and Implant Survival and Success

NCT04741594 | Completed Results DMC FDA Device

• 1 other identifier: 12966
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Missing Teeth

Outcome Measures

Primary Outcomes (1)

• Bone Width (mm)

  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

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

Secondary Outcomes (2)

• Implant Stability

  approximately 3 months

• Number of Implants That Survived

  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.

Study Arms (1)

Versah group

EXPERIMENTAL

Device: Densah

Interventions

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.

Versah group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

College of Dentistry, OUHSC

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Director of Graduate Periodontics Program
• Organization: University of Oklahoma College of Dentistry

tracey-whitley@ouhsc.edu

4052718000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 5, 2021
• Study Start: July 1, 2021
• Primary Completion: February 21, 2022
• Study Completion: September 13, 2023
• Last Updated: June 8, 2026
• Results First Posted: June 8, 2026

Record last verified: 2026-05

Locations

US (1)