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The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
| |
| C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ | Device | OsseoSpeed™ implant |
| |
| NobelSpeedy™ Replace® |
| Measure | Description | Time Frame |
|---|---|---|
| Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. | Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period. | Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level Alterations | Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement. | Evaluated at time of implant installation and at the 5-year follow-up visit. |
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Inclusion Criteria:
The following should be considered at inclusion but can not be fulfilled until at Visit 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Cooper, Prof. | University of Illinois College of Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa, College of Dentistry | Iowa City | Iowa | 52242-1010 | United States | ||
| University of North Carolina, School of Dentistry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25738335 | Result | McGuire MK, Scheyer T, Ho DK, Stanford CM, Feine JS, Cooper LF. Esthetic outcomes in relation to implant-abutment interface design following a standardized treatment protocol in a multicenter randomized controlled trial--a cohort of 12 cases at 1-year follow-up. Int J Periodontics Restorative Dent. 2015 Mar-Apr;35(2):149-59. doi: 10.11607/prd.2341. | |
| 26009913 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group-A. OsseoSpeed™ Implant | Subjects that had OsseoSpeed™ implants installed. |
| FG001 | Group-B. NobelSpeedy™ Replace® Implant | Subjects that had NobelSpeedy™ Replace® implants installed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
NobelSpeedy™ Replace® implant |
|
| NanoTite™ Certain® PREVAIL® | Device | NanoTite™ Certain® PREVAIL® implant |
|
| Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. | Measured at time of loading of permanent restoration and at the 5-year follow-up. |
| Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit. | Measured at the implant loading and at the 5-year follow-up after loading. |
| Chapel Hill |
| North Carolina |
| 27599-7450 |
| United States |
| Perio Health Clinical Research Center | Houston | Texas | 77063 | United States |
| Faculty of Dentistry, McGill University | Montreal | Quebec | H3A 2K6 | Canada |
| Cooper LF, Reside G, Stanford C, Barwacz C, Feine J, Abi Nader S, Scheyer ET, McGuire M. A multicenter randomized comparative trial of implants with different abutment interfaces to replace anterior maxillary single teeth. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):622-32. doi: 10.11607/jomi.3772. |
| 26096162 | Result | Barwacz CA, Stanford CM, Diehl UA, Qian F, Cooper LF, Feine J, McGuire M. Electronic assessment of peri-implant mucosal esthetics around three implant-abutment configurations: a randomized clinical trial. Clin Oral Implants Res. 2016 Jun;27(6):707-15. doi: 10.1111/clr.12640. Epub 2015 Jun 21. |
| FG002 | Group-C. NanoTite™ Certain® PREVAIL® Implant | Subjects that had NanoTite™ Certain® PREVAIL® implants installed |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group-A. OsseoSpeed™ Implant | Subjects that had OsseoSpeed™ implants installed. |
| BG001 | Group-B. NobelSpeedy™ Replace® Implant | Subjects that had NobelSpeedy™ Replace® implants installed |
| BG002 | Group-C. NanoTite™ Certain® PREVAIL® Implant | Subjects that had NanoTite™ Certain® PREVAIL® implants installed |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. | Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period. | A total of 88 subjects completed the 5-year follow-up visit. Five radiographs (two in group A, two in group B and one in group C) were not possible to evaluate, giving an overall number of 83 subjects (83 implants) as basis for the analysis of Gingival Zenith score change. | Posted | Mean | Standard Deviation | Millimeter | Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading | Implants | Implants |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Marginal Bone Level Alterations | Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement. | A total of 88 subjects completed the 5-year follow-up visit. Three radiographs (all in group C) were not possible to evaluate, giving an overall number of 85 subjects (85 implants) as basis for the analysis of marginal bone level change. | Posted | Mean | Standard Deviation | Millimeter | Evaluated at time of implant installation and at the 5-year follow-up visit. |
| |||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD | Condition of the periimplant mucosa by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. | A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the PPD assessment. | Posted | Mean | Standard Deviation | Millimeter | Measured at time of loading of permanent restoration and at the 5-year follow-up. |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit. | A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the assessment of BoP change. | Posted | Mean | Standard Deviation | Change in proportion of surfaces | Measured at the implant loading and at the 5-year follow-up after loading. | Surfaces | Surfaces |
|
|
5 years
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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 | Group-A. OsseoSpeed™ Implant | Subjects that had OsseoSpeed™ implants installed. | 8 | 48 | 8 | 48 | ||
| EG001 | Group-B. NobelSpeedy™ Replace® Implant | Subjects that had NobelSpeedy™ Replace® implants installed | 3 | 49 | 23 | 49 | ||
| EG002 | Group-C. NanoTite™ Certain® PREVAIL® Implant | Subjects that had NanoTite™ Certain® PREVAIL® implants installed | 8 | 44 | 10 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Hospitalized due to fever after mastectomy | Infections and infestations | Systematic Assessment |
| ||
| Hospitalized for partial nephrectomy | Renal and urinary disorders | Systematic Assessment |
| ||
| Hospitalised for gall bladder surgery | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hospitalized for follow-up on chest pains | Cardiac disorders | Systematic Assessment |
| ||
| Hospitalized for spine fusion surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hospitalized for gastric surgery | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hospitalized for surgery of infected appendix | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hospitalized for knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hospitalization after heart attack | Cardiac disorders | Systematic Assessment |
| ||
| Death caused by heart attack | Cardiac disorders | Systematic Assessment |
| ||
| Hospitalized due to episode of bi-polar disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Hospitalized for fractured leg after an accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hospitalized due to pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hospitalization due to hypertension | Vascular disorders | Systematic Assessment |
| ||
| Colon cancer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hospitalized for treatment of infection after vaccination | Infections and infestations | Systematic Assessment |
| ||
| Hospitalized due to menstrual hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study implant failled to osseointegrate | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Study implant temporary mobile | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Restoration failure | Product Issues | Systematic Assessment | Fractured/mobile/de-bonded dental crown on the study implant. |
| |
| Loose abutments | Product Issues | Systematic Assessment | Abutment screws temporarily loose |
| |
| Other | General disorders | Systematic Assessment | Mixed Adverse Events Pain (less the 5% per category). Including: swelling of soft tissue, bone loss around implant, fistula, infection, food impaction in tooth etc., etc. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
| 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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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Units | Counts |
|---|---|
| Participants |
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| Counts |
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| Participants |
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| Participants |
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| Surfaces |
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