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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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

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Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

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

Intervention Type 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)

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)

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No