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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
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The aim of this study is to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of fully edentulous mandibles, supporting a screw-retained full-arch cantilever bridge.
The use of short dental implants provides undeniable benefits in sites where the reduced available volume would otherwise need bone augmentation procedures and their use has greatly expanded in the recent years. However, well designed clinical trials which provide a sound evidence of their performance and reliability are still lacking to date.
In this post-market, multi-center, open, parallel-group, randomized, controlled clinical trial the investigators aim to to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants supporting a mandibular screw-retained full-arch cantilever bridge.
Five 4mm-wide/6mm-long (test) or 4mm-wide/≥11mm-long (control) titanium dental implants (Osseospeed™, ASTRA TECH Implant System™, Dentsply Sirona) are placed in the interforaminal region of fully edentulous mandibles, in non-regenerated sites, with at least 1 mm of peri-implant bone circumferentially.
All products are CE (European Conformity) marked and used within their intended use.
Two-Stage surgery is performed, implants are positioned in healed bone and exposed after 3 months to be connected with the prosthesis.
This is a medium-term follow-up study including evaluations also at 1 and 3 years from the baseline.
Three italian centers participate: Naples (University of Campania "Luigi Vanvitelli"), Naples (AORN "A. Cardarelli"), Catania (Private Office).
The study protocol has been approved by the Institutional Review Board of the University of Campania "Luigi Vanvitelli".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short implants | Experimental | A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm) |
|
| Long implants | Active Comparator | A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm | Device | Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm) |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Bone Level (MBL) Change | Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders. | 5 years from baseline (prosthetic loading) |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival Rate | A surviving implant is defined as an implant in place at the time of the follow-up. Any implant loss shall be assessed as an early loss (implant fails before being osseointegrated) or late loss (after being osseointegrated). | 5 years from baseline (prosthetic loading) |
| Prosthesis Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Guida, Prof | University of Campania Luigi Vanvitelli | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3527955 | Background | Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available. | |
| 25123762 | Background | Nisand D, Renouard F. Short implant in limited bone volume. Periodontol 2000. 2014 Oct;66(1):72-96. doi: 10.1111/prd.12053. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Implants | A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm) |
| FG001 | Long Implants | A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Implants | A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm) |
| 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 | Marginal Bone Level (MBL) Change | Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders. | Posted | Mean | Standard Deviation | mm | 5 years from baseline (prosthetic loading) |
|
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 | Short Implants | A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Marco Annunziata | University of Campania "Luigi Vanvitelli" | 0815665515 | 0039 | marco.annunziata@unicampania.it |
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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 20, 2019 | Nov 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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|
| ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm | Device | Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) |
|
A surviving prosthesis is defined as still in place at the time of the follow-up. |
| 5 years from baseline (prosthetic loading) |
| Biological Complications | Peri-implant mucositis and peri-implantitis | 5 years from baseline (prosthetic loading) |
| Technical Complications | Technical complications are categorized in minor and major complications. The formers require only chair-side repair and include screw loosening and veneer material fracture. The latters require additional laboratory procedures and/or replacement components and include prosthesis or framework fracture, screw fracture, implant fracture, and extended wear requiring veneer renewal. | 5 years from baseline (prosthetic loading) |
| 14714838 | Background | Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8. |
| 23413956 | Background | Srinivasan M, Vazquez L, Rieder P, Moraguez O, Bernard JP, Belser UC. Survival rates of short (6 mm) micro-rough surface implants: a review of literature and meta-analysis. Clin Oral Implants Res. 2014 May;25(5):539-45. doi: 10.1111/clr.12125. Epub 2013 Feb 18. |
| 19681932 | Background | Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x. |
| 31605405 | Result | Guida L, Annunziata M, Esposito U, Sirignano M, Torrisi P, Cecchinato D. 6-mm-short and 11-mm-long implants compared in the full-arch rehabilitation of the edentulous mandible: A 3-year multicenter randomized controlled trial. Clin Oral Implants Res. 2020 Jan;31(1):64-73. doi: 10.1111/clr.13547. Epub 2019 Oct 29. |
| 36461704 | Result | Guida L, Esposito U, Sirignano M, Torrisi P, Annunziata M, Cecchinato D. 6 mm short versus 11 mm long inter-foraminal implants in the full-arch rehabilitation of edentulous non-atrophic mandibles: 5-year results from a multicenter randomized controlled trial. Clin Oral Implants Res. 2023 Feb;34(2):127-136. doi: 10.1111/clr.14024. Epub 2022 Dec 13. |
| BG001 | Long Implants | A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking habit | Count of Participants | Participants |
|
| OG001 | Long Implants | A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) |
|
|
| Secondary | Implant Survival Rate | A surviving implant is defined as an implant in place at the time of the follow-up. Any implant loss shall be assessed as an early loss (implant fails before being osseointegrated) or late loss (after being osseointegrated). | Posted | Number | Implants | 5 years from baseline (prosthetic loading) |
|
|
|
| Secondary | Prosthesis Survival | A surviving prosthesis is defined as still in place at the time of the follow-up. | Posted | Number | Prostheses | 5 years from baseline (prosthetic loading) |
|
|
|
| Secondary | Biological Complications | Peri-implant mucositis and peri-implantitis | Posted | Count of Participants | Participants | 5 years from baseline (prosthetic loading) |
|
|
|
| Secondary | Technical Complications | Technical complications are categorized in minor and major complications. The formers require only chair-side repair and include screw loosening and veneer material fracture. The latters require additional laboratory procedures and/or replacement components and include prosthesis or framework fracture, screw fracture, implant fracture, and extended wear requiring veneer renewal. | Posted | Count of Participants | Participants | 5 years from baseline (prosthetic loading) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Long Implants | A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm: Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) | 0 | 15 | 0 | 15 | 0 | 15 |
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| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |