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

October 21, 2020 updated by: Luigi Guida, University of Campania "Luigi Vanvitelli"

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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)
Active Comparator: 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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone level (MBL) change
Time Frame: 1, 3 and 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.
1, 3 and 5 years from baseline (prosthetic loading)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival rate
Time Frame: 1, 3 and 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).
1, 3 and 5 years from baseline (prosthetic loading)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Collaborators

Dentsply Sirona Implants and Consumables

Investigators

  • Principal Investigator: Luigi Guida, Prof, University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

March 31, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEAOUSUN1327012010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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