Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible
- Conditions
- Edentulous Jaw
- Registration Number
- NCT03509402
- Lead Sponsor
- University of Campania Luigi Vanvitelli
- Brief 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- total edentulous patients in the lower region since at least 8 months,
- sufficient amount of native bone (no augmentation procedures) in the recipient sites to allow ≥11 mm long and 4 mm wide implant installation (≥1 mm of peri-implant bone circumferentially)
- systemic health
- compliance with good oral hygiene
- informed consent signed.
- any disease, medication or drug that could jeopardize healing, osseointegration or treatment outcome,
- untreated caries or periodontitis of the remaining teeth,
- mucosal and bone tissue lesions,
- severe bruxism or other parafunction habits,
- unrealistic aesthetic demands,
- patient taking part to another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Marginal Bone Level (MBL) Change 5 years from baseline (prosthetic loading) 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.
- Secondary Outcome Measures
Name Time Method Implant Survival Rate 5 years from baseline (prosthetic loading) 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).
Prosthesis Survival 5 years from baseline (prosthetic loading) A surviving prosthesis is defined as still in place at the time of the follow-up.
Biological Complications 5 years from baseline (prosthetic loading) Peri-implant mucositis and peri-implantitis
Technical Complications 5 years from baseline (prosthetic loading) 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.