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| Name | Class |
|---|---|
| Institut Straumann AG | INDUSTRY |
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The investigators are asking subjects to take part in a research study of soft tissue (gums) and bone (jawbone) healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes 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 as part of standard care but it is not known if the two procedures are equally good since they have never been compared in one same research study.
This controlled, randomized clinical trial (RCT) is designed to compare soft and hard tissue dimensional changes for two commonly used approaches for replacing a recently extracted tooth by means of a dental implant, i.e. immediate implant placement (Type 1) or early implant placement (Type 2). Additionally, this study will evaluate the association between the osseous anatomy and implant position with soft and hard tissue changes.
Extraction sites will include maxillary and mandibular anterior and premolar teeth having intact adjacent teeth. Implants placed for this study will be SLA surface, bone level design, Straumann BL RC (Bone Level Regular Cross-fit ) 4.1mm or BL NC (Bone Level Narrow Cross-fit ) 3.3mm diameter implants at 8, 10, 12 or 14mm in length.
Immediate implant placement (Type 1) resulting in a horizontal defect dimension (HDD) will receive bone grafting, using freeze dried bone allograft (FDBA)(Straumann Allograft GC®) and will be covered by a resorbable membrane (BioGide®).
For the implants randomized to type 2 implant placement, the extraction socket will be filled with a collagen plug and allowed to heal for 4 to 8 weeks before the implant will be placed. Simultaneous guided bone regeneration (GBR) will be performed using FDBA (Straumann Allograft GC®)and a resorbable collagen membrane (BioGide®). The type 2 implant placement procedure will follow the guidelines as described by Buser et al. (2008).
All implant placement will follow standard protocols utilizing tapping and placement according to the manufacturer's guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 implant placement | Active Comparator | Placement of a dental implant: Implant is placed immediately following tooth extraction in one surgical procedure |
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| Type 2 implant placement | Active Comparator | Placement of a dental implant: Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of a dental implant | Procedure | Type 1 implant placement Type 2 implant placement |
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| 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, 24, 36, 48, 60 months after crown delivery. | 3 months after crown delivery |
| Measure | Description | Time Frame |
|---|---|---|
| PES/WES (Pink Esthetic Score, White Esthetic Score). | The PES and WES 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. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported. |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Implant Placement | Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement |
| FG001 | Type 2 Implant Placement |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
| Probing Depth | The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported. | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
| Modified Plaque Index | 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. | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
| Modified Bleeding Index | 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. | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
| Radiographic Bone Level | Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery. | Up to 5 years after baseline |
Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.
Placement of a dental implant: Type 1 implant placement Type 2 implant placement
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Implant Placement | Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement |
| BG001 | Type 2 Implant Placement | Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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, 24, 36, 48, 60 months after crown delivery. | Posted | Mean | Standard Deviation | mm | 3 months after crown delivery |
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| Secondary | PES/WES (Pink Esthetic Score, White Esthetic Score). | The PES and WES 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. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported. | Posted | Mean | Standard Error | units on a scale | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
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| Secondary | Probing Depth | The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported. | Posted | Mean | Standard Error | mm | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
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| Secondary | Modified Plaque Index | 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 Error | units on a scale | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
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| Secondary | Modified Bleeding Index | 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 Error | units on a scale | 3, 6, 12, 24, 36, 48, 60 months after crown delivery |
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| Secondary | Radiographic Bone Level | Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery. | No data were collected or analyzed for this outcome measure | Posted | Up to 5 years after baseline |
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Up to 3 months after crown delivery
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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 Placement | Implant is placed immediately following tooth extraction in one surgical procedure Placement of a dental implant: Type 1 implant placement Type 2 implant placement | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | Type 2 Implant Placement | Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure. Placement of a dental implant: Type 1 implant placement Type 2 implant placement | 0 | 15 | 0 | 15 | 2 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling and bruising | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guy Huynh-Ba | UTHSCSA Periodontics | 2105673569 | huynhba@uthscsa.edu |
| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth 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 |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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