An interventional study of abutment margin 0.5 mm subgingival and abutment margin 1.5 mm subgingival in Single Edentulous Space, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
This study's enrollment of 22 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline
Device: abutment margin 0.5 mm subgingival
when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline
Device: abutment margin 1.5 mm subgingival
Number of Participants With Abutment Margin Exposure > 0
Margin exposure of the abutment between groups at 6 months post surgery.
Time frame: up to 6 months post surgery
Number of Participants With a Soft Tissue Response of Bleeding
To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.
Time frame: 6 months post surgery
Number of Participants With Provisional Crown Fit at Delivery
To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'
Time frame: 8 weeks post surgery
| Milestone | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival |
|---|---|---|
| Started | 11 | 11 |
| Completed | 5 | 9 |
| Not completed | 6 | 2 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Implant failure | 4 | 1 |
Margin exposure of the abutment between groups at 6 months post surgery.
| Participants | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival |
|---|---|---|
| Number of Participants With Abutment Margin Exposure > 0 | 0 | 0 |
To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.
| Participants | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival |
|---|---|---|
| Yes bleeding | 3 | 8 |
| No bleeding | 2 | 1 |
To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'
| Participants | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival |
|---|---|---|
| Yes | 3 | 5 |
| No | 2 | 4 |
Collected over From the date of consent until six months after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abutment Margin 0.5 mm Subgingival | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Abutment Margin 1.5 mm Subgingival | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 7 | 16 |
| >=65 years | 2 | 4 | 6 |
| Sex: Female, Male(Participants) | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival | Total |
|---|---|---|---|
| Female | 4 | 8 | 12 |
| Male | 7 | 3 | 10 |
| Race (NIH/OMB)(Participants) | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 8 | 6 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
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University of North Carolina, Chapel Hill