Back to resultsOsseodensification and Implant Survival and Success
Primary Purpose
Missing Teeth
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Densah
Sponsored by
About this trial
This is an interventional treatment trial for Missing Teeth
Eligibility Criteria
4. 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
Sites / Locations
- College of Dentistry, OUHSCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Versah group
Arm Description
Outcomes
Primary Outcome Measures
Bone width (mm)
Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge.
Secondary Outcome Measures
implant stability
Implant stability quotient (ISQ) values
Survival and failure rate
Rates of survival and failure rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04741594
Brief Title
Osseodensification and Implant Survival and Success
Official Title
Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Versah group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Densah
Intervention Description
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 Outcome Measure Information:
Title
Bone width (mm)
Description
Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
implant stability
Description
Implant stability quotient (ISQ) values
Time Frame
2 years
Title
Survival and failure rate
Description
Rates of survival and failure rate
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
4. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasim Lasemi, DDS
Phone
405-271-7020
Email
Nasim-Lasemi@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Xixi Wu, Ph.D
Phone
405-271-7020
Facility Information:
Facility Name
College of Dentistry, OUHSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasim Lasemi
Phone
217-722-7671
Email
Nasim-Lasemi@ouhsc.edu
12. IPD Sharing Statement
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Osseodensification and Implant Survival and Success
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