NCT03509402

Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible

Short vs Long Implants Supporting a Total Fixed Prosthetic Rehabilitation of the Fully Edentulous Mandible. A Multicenter Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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".

Conditions

• Edentulous Jaw

Interventions

Type	Name	Description
DEVICE	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)
DEVICE	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)

Timeline

• Start date: 2010-01-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2018-04-26
• Last updated: 2025-01-13
• Results posted: 2025-01-13