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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abutment margin 0.5 mm subgingival | Other | when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline |
|
| abutment margin 1.5 mm subgingival | Other | when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abutment margin 0.5 mm subgingival | Device |
| ||
| abutment margin 1.5 mm subgingival |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abutment Margin Exposure > 0 | Margin exposure of the abutment between groups at 6 months post surgery. | up to 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingeborg De Kok, DDS | University of North Carolina School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abutment Margin 0.5 mm Subgingival | When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival |
| FG001 | Abutment Margin 1.5 mm Subgingival | When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abutment Margin 0.5 mm Subgingival | When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival |
| BG001 | Abutment Margin 1.5 mm Subgingival |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Abutment Margin Exposure > 0 | Margin exposure of the abutment between groups at 6 months post surgery. | Posted | Count of Participants | Participants | up to 6 months post surgery |
|
From the date of consent until six months after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abutment Margin 0.5 mm Subgingival | When fabricating an abutment to support the crown, the margin will be placed 0.5mm below the gumline abutment margin 0.5 mm subgingival |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gidgetta Jenkins | University of North Carolina at Chapel Hill | 919-537-3968 | gidget_jenkins@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2014 | May 18, 2018 | Prot_SAP_000.pdf |
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| Device |
|
| 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.' |
| 8 weeks post surgery |
When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months post surgery |
|
|
|
|
| Secondary | 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.' | Posted | Count of Participants | Participants | 8 weeks post surgery |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Abutment Margin 1.5 mm Subgingival | When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival | 0 | 11 | 0 | 11 | 0 | 11 |
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