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To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoSpeed™ TX 3.0S (Dental implant) | Experimental | OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ TX 3.0S | Device | OsseoSpeed™ TX 3.0 mm diameter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | Overall implant survival rate evaluated clinically and radiographically | Evaluated at implant placement and at the 5 years follow-up after implant placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Galindo Moreno, Assoc. Prof. | University of Granada: School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tand-mund-kaebekirurgisk Klinik | Copenhagen | 2100 | Denmark | |||
| Bundeswehrkrankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22093047 | Result | Galindo-Moreno P, Nilsson P, King P, Becktor J, Speroni S, Schramm A, Maiorana C. Clinical and radiographic evaluation of early loaded narrow diameter implants - 1-year follow-up. Clin Oral Implants Res. 2012 May;23(5):609-16. doi: 10.1111/j.1600-0501.2011.02254.x. Epub 2011 Sep 28. | |
| 25650268 | Result | Maiorana C, King P, Quaas S, Sondell K, Worsaae N, Galindo-Moreno P. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 3 years follow-up. Clin Oral Implants Res. 2015;26(1):77-82. doi: 10.1111/clr.12281. Epub 2013 Oct 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed™ TX 3.0 | OsseoSpeed™ TX 3.0 mm diameter implants (lengths 11 mm, 13 mm and 15 mm). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of enrolled participants that completed surgery (Baseline)
| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed™ TX 3.0S | OsseoSpeed™ TX 3.0 mm diameter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Implant Survival Rate | Overall implant survival rate evaluated clinically and radiographically | A total of 69 subjects were enrolled in the study and received a total of 97 implants. | Posted | Count of Units | Implants | Evaluated at implant placement and at the 5 years follow-up after implant placement | Implants | Implants |
|
|
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 | OsseoSpeed™ TX 3.0S | OsseoSpeed™ TX 3.0 mm diameter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crown loss | Product Issues | Non-systematic Assessment | 10 subjects experienced temporary crown loss. Resolved by having the crowns re-cemented. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
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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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| Ulm |
| D-89081 |
| Germany |
| Clinica Odontoiatrica | Milan | 20123 | Italy |
| Department Oral Surgery, University of Granada: School of Dentistry | Granada | 18071 | Spain |
| Käkkirurgiska kliniken, Odontologiska Institutionen | Jönköping | 551 11 | Sweden |
| Bristol Dental Hospital and School | Bristol | BS1 2LY | United Kingdom |
| 26929953 | Result | King P, Maiorana C, Luthardt RG, Sondell K, Oland J, Galindo-Moreno P, Nilsson P. Clinical and Radiographic Evaluation of a Small-Diameter Dental Implant Used for the Restoration of Patients with Permanent Tooth Agenesis (Hypodontia) in the Maxillary Lateral Incisor and Mandibular Incisor Regions: A 36-Month Follow-Up. Int J Prosthodont. 2016 Mar-Apr;29(2):147-53. doi: 10.11607/ijp.4444. |
| 28626888 | Result | Galindo-Moreno P, Nilsson P, King P, Worsaae N, Schramm A, Padial-Molina M, Maiorana C. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 5-year follow-up of a multicenter prospective clinical study. Clin Oral Implants Res. 2017 Dec;28(12):1584-1591. doi: 10.1111/clr.13029. Epub 2017 Jun 18. |
| Implants |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Implants |
|
|
| 0 |
| 69 |
| 39 |
| 69 |
|
| Abutment fractures | Product Issues | Non-systematic Assessment | 7 subjects experienced implant abutment fractures |
|
| Implant lost | Product Issues | Non-systematic Assessment | 4 participants lost their implants. 3 due to insufficient osseointegration and 1 due to infection. All 4 implants were lost during the healing phase before loading of the implant. |
|
| Common cold | Infections and infestations | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment | Headache and/or Migraine |
|
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |