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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20130085H | Other Identifier | UTHSCSA IRB |
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| Name | Class |
|---|---|
| ITI International Team for Implantology, Switzerland | OTHER |
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In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios:
Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely but they have never been compared objectively to one another in the same research study.
The main purpose of this study is to evaluate if there is any difference in terms of esthetic outcomes between these two treatment modalities after a crown has been placed on the implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 implant and thin biotype | Active Comparator | In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed. |
|
| Type 1 implant and thick biotype | Active Comparator | In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLActive implant | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mid Facial Mucosal Level at Implant Site | Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery. | Change from Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PES/WES (Pink Esthetic Score, White Esthetic Score). | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Huynh-Ba, DDS, MS | UTHSCSA Department of Periodontics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graduate Periodontics, Dental School, UTHSCSA | San Antonio | Texas | 78229 | United States |
No patient was excluded prior to group assignment.
The recruitment started in January 2013 and ended in November 2016. All patient were recruited at the University of Texas Health San Antonio, Department of Periodontics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Implant and Thick Biotype | In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket. SLActive implant |
| FG001 | Type 1 Implant and Thin Biotype | In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed. SLActive implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Each patient received one dental implant which was included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Implant and Thick Biotype | In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket. SLActive implant |
| BG001 | Type 1 Implant and Thin Biotype |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Mid Facial Mucosal Level at Implant Site | Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery. | Posted | Mean | Standard Deviation | mm | Change from Baseline to 3 months |
|
Research related adverse events were collected throughout the study period, up to 1 year.
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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 | Type 1 Implant and Thick Biotype | In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket. SLActive implant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Compliance Coordinator-Senior | UT Health San Antonio | 210-567-8554 | NijlandK@uthscsa.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 | Jun 6, 2014 | Apr 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| Approximately 1 year after baseline |
| Probing Depth | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported. | Up to 1 year after baseline |
| Modified Plaque Index | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported. | Up to 1 year after baseline |
| Modified Bleeding Index | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported. | Up to 1 year after baseline |
| Radiographic Bone Level | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact. | Up to 1 year after baseline |
In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed. SLActive implant |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | PES/WES (Pink Esthetic Score, White Esthetic Score). | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome. | Posted | Mean | Standard Deviation | score on a scale | Approximately 1 year after baseline |
|
|
|
| Secondary | Probing Depth | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported. | Posted | Mean | Standard Deviation | mm | Up to 1 year after baseline |
|
|
|
| Secondary | Modified Plaque Index | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 year after baseline |
|
|
|
| Secondary | Modified Bleeding Index | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 year after baseline |
|
|
|
| Secondary | Radiographic Bone Level | Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact. | Posted | Mean | Standard Deviation | mm | Up to 1 year after baseline |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Type 1 Implant and Thin Biotype | In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed. SLActive implant | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| 12 months (Mesial) |
|
| Baseline at Crown Delivery (Distal Measurement) |
|
| 3 months (distal) |
|
| 12 months (distal) |
|
| Baseline at Crown Delivery (Buccal Measurement) |
|
| 3 months (Buccal) |
|
| 12 months (Buccal) |
|
| Baseline at Crown Delivery (Proximal measurement) |
|
| 3 months (proximal) |
|
| 12 months (proximal) |
|
| 12 months (Mesial) |
|
| Baseline at Crown Delivery (Distal Measurement) |
|
| 3 months (distal) |
|
| 12 months (distal) |
|
| Baseline at Crown Delivery (Buccal Measurement) |
|
| 3 months (Buccal) |
|
| 12 months (Buccal) |
|
| Baseline at Crown Delivery (Proximal measurement) |
|
| 3 months (proximal) |
|
| 12 months (proximal) |
|
| 12 months (Mesial) |
|
| Baseline at Crown Delivery (Distal Measurement) |
|
| 3 months (distal) |
|
| 12 months (distal) |
|
| Baseline at Crown Delivery (Buccal Measurement) |
|
| 3 months (Buccal) |
|
| 12 months (Buccal) |
|
| Baseline at Crown Delivery (Proximal measurement) |
|
| 3 months (proximal) |
|
| 12 months (proximal) |
|
| Baseline to 12 months BIC (Mesial) |
|
| Baseline to 3 months BIC (Distal Measurement) |
|
| 3 to 12 months BIC (distal) |
|
| Baseline to 12 months BIC (distal) |
|