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The purpose of this study is to compare how well our research participants heal with two different kind of healing abutments used. One is pre-fabricated, meaning it is made to fit anyone, and the other is customized to fit the subject specifically. Much of what will occur is 'standard of care' meaning it is part of a subject's typical dental treatment and the research team wants to just look at the data for this research study, as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Pre Fabricated Healing Abutment | Active Comparator | Subjects that are randomized into the control group will have a pre-fabricated healing abutment used. |
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| Investigational: Customized Healing Abutment | Experimental | Subjects that are randomized into the control group will have a customized healing abutment used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healing Abutment- customized | Device | A customized healing abutment will be used on subjects in this study as part of their implant healing process. |
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| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue healing progress | Clinical Evaluation of Soft Tissue Healing; the clinician will perform intraoral examination on tissue color, contour, signs of inflammation, presence of keratinized tissue and soft tissue integration around the healing abutment. These are all visual observations and will be recorded as Yes/No. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome of gingival appearance | gingival appearance- reported through visual observation of presence of gingiva and color of implant and healing abutment. This observation is just on general healing progress related to this outcome, nothing is measured on a scale. | 3 months |
| Functional outcome of implant esthetic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Mordini | Contact | 857-299-4168 | Lorenzo.Mordini@tufts.edu | |
| Ann-Marie Jacobson | Contact | dentalresearchadministration@tufts.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Mordini | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Healing Abutment- pre fabricated | Device | A pre-fabricated (pre- made) healing abutment will be used on subjects in this study as part of their implant healing process. |
|
Implant esthetics - reported through visual observation of presence of gingiva and color of implant and healing abutment. This observation is just on general healing progress related to this outcome, nothing is measured on a scale. |
| 3 months |