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NCT04741594 · ClinicalTrials.gov registry record · NA
Osseodensification and Implant Survival and Success
A NA study of Missing Teeth, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04741594: Completed NA study of Missing Teeth, sponsored by University of Oklahoma.
NCT04741594 is a NA study of Missing Teeth that has completed, run by University of Oklahoma. The registered enrollment target is 22 participants, below the 29-participant average among 4 other Missing Teeth trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04741594, a NA study of Missing Teeth, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Densah
Study Locations (1)
Oklahoma
- College of Dentistry, OUHSC - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2023-09-13 |
| Phase | NA |
What the finished NCT04741594 record still lists
NCT04741594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 29-participant average among 4 other Missing Teeth trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Missing Teeth appearing as the primary indexed condition, and to 1 intervention - of which Densah is the first listed.
NCT04741594 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT04741594 about?
NCT04741594 is a clinical study titled "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 manufa...
What is the current status of trial NCT04741594?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2021-07-01. Estimated completion is 2023-09-13.
What conditions does trial NCT04741594 study?
This clinical trial studies the following conditions: Missing Teeth.
What interventions are being tested in trial NCT04741594?
The interventions under investigation include: Densah (DEVICE).
Who is sponsoring clinical trial NCT04741594?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04741594 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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