Missing TeethNCT04741594
Osseodensification and Implant Survival and Success
A study testing Densah in people with Missing Teeth, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Densah
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
College of Dentistry, OUHSC
Oklahoma City, Oklahoma, 73117
About this study
Official title: Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series
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.
Read the detailed description
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.
- Conditions
- Missing Teeth
- Being tested
- Densah
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DensahDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Versah group | Experimental | The use of a Versah bur, which is an implant drill bit, is different than a standard implant drill bit, in that its use creates a more dense bone, by using a technique called osseodensification. The drill bit and technique are specific to this drill bit and protocol, resulting in denser bone for subsequent implant placement. Receives: Device: Densah |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measurements were taken at baseline and 3 months after implant placement.
Secondary outcomes (2)
Change in Implant Stability
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.
Measured: From Initial Placement to 3 month follow-up - approximately 3 months
Number of Implants That Survived
This outcome measure emphasizes the number of implants in this study that have survived for analysis.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Jul 2021
- Primary completion21 Feb 2022
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Henderson, Study director, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741594
- Sponsor's protocol ID
- 12966
- Status last verified
- Jun 2026
- First submitted
- 15 Jan 2021
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Expansion by Osseodensification and Its Impact on Implant Survival and Success: A Case Series
- ClinicalTrials.gov ID
- NCT04741594
- Acronym / sponsor ID
- 12966
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Versah group | Experimental | Device: DensahThe use of a Versah bur, which is an implant drill bit, is different than a standard implant drill bit, in that its use creates a more dense bone, by using a technique called osseodensification. The drill bit and technique are specific to this drill bit and protocol, resulting in denser bone for subsequent implant placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DensahAlveolar 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. | Device | Versah group |
Primary outcome
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
2 secondary outcomes
Change in Implant Stability
Time frame: From Initial Placement to 3 month follow-up - approximately 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Henderson study director
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Densah in people with Missing Teeth, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Width (mm) (time frame: Measurements were taken at baseline and 3 months after implant placement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.