Single Edentulous Space
Conditions
Brief summary
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.
Interventions
DEVICEabutment margin 0.5 mm subgingival
DEVICEabutment margin 1.5 mm subgingival
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* partially edentulous with single edentulous space * edentulous site where previous tooth has been extracted for at least two months * minimum of 20 teeth present * able to tolerate dental implant surgical and restorative procedures * consent to participate in clinical trial
Exclusion criteria
* asa class 3+ * present drug use * is pregnant or plans to become pregnant * patients in need of lateral window sinus graft * patients in need of grafting prior to implant placement * patients in need of extensive grafting at time of implant placement * tooth is present or extracted within the last 2 months * history of IV bisphosphonate use or oral bisphosphonate use contraindicating dental implant therapy * untreated caries or periodontal disease * severe bruxism * smoker within past 6 months * unlikely to be able to comply with study procedures according to investigators * known allergy to any materials used in dental implant surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abutment Margin Exposure > 0 | up to 6 months post surgery | Margin exposure of the abutment between groups at 6 months post surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Soft Tissue Response of Bleeding | 6 months post surgery | 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. |
| Number of Participants With Provisional Crown Fit at Delivery | 8 weeks post surgery | To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.' |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| 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 | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Implant Failure | 4 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Abutment Margin 0.5 mm Subgingival | Abutment Margin 1.5 mm Subgingival | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 14 Participants |
| Region of Enrollment United States | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abutment Margin 0.5 mm Subgingival | Number of Participants With Abutment Margin Exposure > 0 | 0 Participants |
| Abutment Margin 1.5 mm Subgingival | Number of Participants With Abutment Margin Exposure > 0 | 0 Participants |
p-value: 1Fisher Exact
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.
Time frame: 6 months post surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abutment Margin 0.5 mm Subgingival | Number of Participants With a Soft Tissue Response of Bleeding | Yes bleeding | 3 Participants |
| Abutment Margin 0.5 mm Subgingival | Number of Participants With a Soft Tissue Response of Bleeding | No bleeding | 2 Participants |
| Abutment Margin 1.5 mm Subgingival | Number of Participants With a Soft Tissue Response of Bleeding | Yes bleeding | 8 Participants |
| Abutment Margin 1.5 mm Subgingival | Number of Participants With a Soft Tissue Response of Bleeding | No bleeding | 1 Participants |
p-value: 0.039Binomial
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.'
Time frame: 8 weeks post surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abutment Margin 0.5 mm Subgingival | Number of Participants With Provisional Crown Fit at Delivery | Yes | 3 Participants |
| Abutment Margin 0.5 mm Subgingival | Number of Participants With Provisional Crown Fit at Delivery | No | 2 Participants |
| Abutment Margin 1.5 mm Subgingival | Number of Participants With Provisional Crown Fit at Delivery | Yes | 5 Participants |
| Abutment Margin 1.5 mm Subgingival | Number of Participants With Provisional Crown Fit at Delivery | No | 4 Participants |
p-value: 1Binomial