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Osseodensification and Implant Survival and Success

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ClinicalTrials.gov Identifier: NCT04741594
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Missing Teeth Device: Densah Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Versah group Device: Densah
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.


Outcome Measures
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Primary Outcome Measures :
  1. Bone width (mm) [ Time Frame: 2 years ]
    Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge.


Secondary Outcome Measures :
  1. implant stability [ Time Frame: 2 years ]
    Implant stability quotient (ISQ) values

  2. Survival and failure rate [ Time Frame: 2 years ]
    Rates of survival and failure rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

4. Inclusion / Exclusion Criteria

The inclusion criteria include:

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

The exclusion criteria include:

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

The early termination criteria include:

  1. The researcher believes that it is not in the patient's best interest to stay in the study
  2. Based on the exclusion criteria, the patient becomes ineligible to participate
  3. Patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
  4. Patient does not follow study related instructions
  5. The study is suspended or canceled
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741594


Contacts
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Contact: Nasim Lasemi, DDS 217-722-7671 Nasim-Lasemi@ouhsc.edu
Contact: Xixi Wu, Ph.D 3472493013 wuxixi86101@gmail.com

Locations
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United States, Oklahoma
College of Dentistry, OUHSC Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Nasim Lasemi    217-722-7671    Nasim-Lasemi@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04741594    
Other Study ID Numbers: 711761
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
 Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities