N/A
N=30
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
Dental Implants
Bottom Line
View on ClinicalTrials.gov: NCT05283928 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Bone Ridge Width at Crest — 0.84; 0.01 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoDensification (OD) protocol (Device); standard drilling (SD) protocol (NobelReplace® Conical) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Ridge Width at Crest |
0.84; 0.01 | — |
| PRIMARY Change in Bone Ridge Width at 5mm Apical From Crest |
0.62; 0.11 | — |
| PRIMARY Change in Bone Ridge Width at 10mm Apical From Crest |
0.29; 0.01 | — |
| SECONDARY Primary Stability of the Implants as Measured by the Insertion Torque Values |
57.7; 45 | — |
| SECONDARY Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement) |
73.7; 67.0 | — |
| SECONDARY Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 3 Weeks After Implant Placement |
75; 69.8 | — |
| SECONDARY Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement |
75.3; 70.8 | — |
| SECONDARY Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement |
76.8; 73.3 | — |
| SECONDARY Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT) |
— | — |
| SECONDARY Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform |
6.24; -21.3 | — |
| SECONDARY Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform |
8.61; -15.1 | — |
Summary
The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols
Eligibility Criteria
Inclusion Criteria
- Patients who understand and agree to this study.
- Adequate Oral hygiene
- One or more edentulous spaces, which are 10 weeks or longer after extractions
Exclusion Criteria
- Pregnancy.
- Smoking of more than 5 cigarettes/day.
- History of alcoholism or drug abuse during the last 5 years.
- Uncontrolled Hypertension or diabetes.
- Patient with malignant tumor.
- Patients on daily dose of steroids.
- Patients with history of chemotherapy or radiation for the last 12 months.
Data sourced from ClinicalTrials.gov (NCT05283928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.