Trials / Unknown
UnknownNCT02397044
"Prospective Evaluation of Immediate & Early Loading of Zimmer Hydroxyapatite Coated Dental Implants"
Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 48 (actual)
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function.
Detailed description
Forty-eight patients (22 men, 26 women) were enrolled in the study and received 48 implants. The population was divided into 2 groups: Group A implants (n=23) were loaded immediately on the day of surgery and Group B implants (n=19) were loaded 3 weeks after surgery. Cone Beam Computed Tomography (CBCT) scans were taken preoperatively to aid in treatment planning. Bone density was evaluated on CBCT scans in Hounsfield units (HU) and by tactile feedback during surgery. Insertion torque was recorded at time of implant placement. Resonance frequency analysis, performed on the day of surgery, at the time of loading, and at 6, 12 and 24 months, was used to record implant stability according to the unit's Implant Stability Quotient (Osstell ISQ). Standardized radiographs were taken at time of implant placement and at 6, 12 and 24 months to measure crestal bone stability. Bone level changes were measured by software (Image J, available online at: http://rsbweb.nih.gov/ij/download.html; last accessed 28 August 2014).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Implant surgery | Compare surgical protocols |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-12-01
- Completion
- 2017-12-01
- First posted
- 2015-03-24
- Last updated
- 2015-03-24
Source: ClinicalTrials.gov record NCT02397044. Inclusion in this directory is not an endorsement.