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

University of Campania Luigi Vanvitelli

Status: Completed

Conditions: Edentulous Jaw

Treatments: Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm; Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03509402

CEAOUSUN1327012010

Details and patient eligibility

About

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.

Full 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".

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Short implants

Experimental group

Description:

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)

Treatment:

Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm

Long implants

Active Comparator group

Description:

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)

Treatment:

Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm