Partially Edentulous Jaw
Conditions
Keywords
dental implants, screw-vent dental implants
Brief summary
The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar. The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.
Detailed description
Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.
Interventions
DEVICEMicrotextured dental implant treatment
Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
DEVICEDental implant treatment
Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
Sponsors
Zimmer Dental
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient 2. Existence of one or more missing teeth scheduled to be replaced with dental implants 3. Healthy enough to undergo proposed therapy without compromising existing health 4. Able to consent for their own inclusion 5. Able to read and understand the informed consent form 6. Demonstrated willingness to comply with protocol requirements and timeline
Exclusion criteria
1. Any health condition that in the opinion of the investigators may adversely affect bone healing 2. Any medication that in the opinion of the investigators may adversely affect bone healing 3. Any indication of an inability to make autonomous decisions 4. Reported pregnancy at the time of enrollment -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Millimeters of Bone Loss Surrounding the Implant Device | Implant insertion, 12 months post-insertion | Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Peri-implant Gingivitis Score | 1 year after placement | Measurement of changes in peri-implant gingivitis score \[Loe and Silness gingival index (GI)\] after implant restoration |
| Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device | 1 year after placement | Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Microtextured Dental Implant Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists. | 37 |
| Dental Implant Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists. | 31 |
| Total | 68 |
Baseline characteristics
| Characteristic | Microtextured Dental Implant | Total | Dental Implant |
|---|---|---|---|
| Age, Customized Greater than 19 years | 37 participants | 68 participants | 31 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 66 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 51 Participants | 23 Participants |
| Region of Enrollment United States | 37 participants | 68 participants | 31 participants |
| Sex: Female, Male Female | 16 Participants | 27 Participants | 11 Participants |
| Sex: Female, Male Male | 21 Participants | 41 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 31 |
| serious Total, serious adverse events | 0 / 37 | 0 / 31 |
Outcome results
Primary
Change in Millimeters of Bone Loss Surrounding the Implant Device
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Time frame: Implant insertion, 12 months post-insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microtextured Dental Implant | Change in Millimeters of Bone Loss Surrounding the Implant Device | -0.35 millimeters | Standard Deviation 0.56 |
| Dental Implant | Change in Millimeters of Bone Loss Surrounding the Implant Device | -0.82 millimeters | Standard Deviation 0.7 |
Secondary
Changes in Peri-implant Gingivitis Score
Measurement of changes in peri-implant gingivitis score \[Loe and Silness gingival index (GI)\] after implant restoration
Time frame: 1 year after placement
Population: No data was collected. Previously entered data was entered incorrectly.
Secondary
Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.
Time frame: 1 year after placement
Population: No data was collected. Previously entered data was entered incorrectly.