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

Primary Purpose

Edentulous Jaw

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw focused on measuring short dental implants, full-arch prosthesis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Short implants

    Long implants

    Arm 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)

    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)

    Outcomes

    Primary Outcome Measures

    Marginal bone level (MBL) change
    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

    Implant survival rate
    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).

    Full Information

    First Posted
    March 31, 2018
    Last Updated
    October 21, 2020
    Sponsor
    University of Campania "Luigi Vanvitelli"
    Collaborators
    Dentsply Sirona Implants and Consumables
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03509402
    Brief Title
    Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible
    Official Title
    Short vs Long Implants Supporting a Total Fixed Prosthetic Rehabilitation of the Fully Edentulous Mandible. A Multicenter Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (Actual)
    Primary Completion Date
    February 2021 (Anticipated)
    Study Completion Date
    February 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"
    Collaborators
    Dentsply Sirona Implants and Consumables

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous Jaw
    Keywords
    short dental implants, full-arch prosthesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Short implants
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    Long implants
    Arm Type
    Active Comparator
    Arm 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)
    Intervention Type
    Device
    Intervention Name(s)
    ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm
    Intervention Description
    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
    Intervention Name(s)
    ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Marginal bone level (MBL) change
    Description
    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.
    Time Frame
    1, 3 and 5 years from baseline (prosthetic loading)
    Secondary Outcome Measure Information:
    Title
    Implant survival rate
    Description
    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).
    Time Frame
    1, 3 and 5 years from baseline (prosthetic loading)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luigi Guida, Prof
    Organizational Affiliation
    University of Campania "Luigi Vanvitelli"
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3527955
    Citation
    Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25123762
    Citation
    Nisand D, Renouard F. Short implant in limited bone volume. Periodontol 2000. 2014 Oct;66(1):72-96. doi: 10.1111/prd.12053.
    Results Reference
    background
    PubMed Identifier
    14714838
    Citation
    Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8.
    Results Reference
    background
    PubMed Identifier
    23413956
    Citation
    Srinivasan M, Vazquez L, Rieder P, Moraguez O, Bernard JP, Belser UC. Survival rates of short (6 mm) micro-rough surface implants: a review of literature and meta-analysis. Clin Oral Implants Res. 2014 May;25(5):539-45. doi: 10.1111/clr.12125. Epub 2013 Feb 18.
    Results Reference
    background
    PubMed Identifier
    19681932
    Citation
    Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x.
    Results Reference
    background

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

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