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Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03908177
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Factory CRO
DFNet Research Inc.
Information provided by (Responsible Party):
Institut Straumann AG

Brief Summary:
A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.

Condition or disease Intervention/treatment Phase
Dental Implants, Single-Tooth Device: Ceramic Dental Implant Device: Titanium Dental Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Performance of Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow: A Multicentre Multinational Randomized Controlled Clinical Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Study Group (SG)
Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA
Device: Ceramic Dental Implant
The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.

Active Comparator: Control Group (CG)
Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA
Device: Titanium Dental Implant
The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.




Primary Outcome Measures :
  1. Bone Level Change [ Time Frame: 12 months after implant loading (final crown restoration) ]
    Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading [mm].


Secondary Outcome Measures :
  1. Implant survival [ Time Frame: 12 months after loading. ]
    Implant survival rates 3, 6 months and 1 year after loading: yes/no

  2. 14 item Oral Health Impact Profile (OHIP-14) [ Time Frame: 12 months after loading. ]
    The local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).


Other Outcome Measures:
  1. Adverse Events [ Time Frame: 16 months after inclusion. ]
    Adverse Events will be recorded at every visit.

  2. Device Deficiencies [ Time Frame: 16 months after inclusion. ]
    Any device complications and deficiencies will be recorded as Device Deficiencies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analysed, and published.
  • Patients must be males or females who are a minimum of 18 years of age.
  • Patients, who are in need of a single tooth replacement with a dental implant in the premolar-to-premolar area in the mandible or maxilla (excluding lower incisors).
  • Presence of natural teeth on both sides of the study implant position and opposing dentition (single tooth gap).
  • Patients with healed extraction sockets, which means that at implant surgery:

    • Soft tissue coverage of the socket is complete; and
    • Alveolar bone is reconsolidated (around 16 weeks after tooth extraction).

Exclusion Criteria:

  • Patients with inadequate bone volume where major bone augmentation would be required at implant location.
  • Inadequate anatomic situation that would prevent prosthetic-driven planning based on CBCT.
  • Presence of implants neighbouring the study implant.
  • Patients with inadequate oral hygiene (FMPS ≥ 20%).
  • Patients with local root remnants.
  • Patients with inadequate wound healing capacity.
  • Patients with incomplete maxillary and mandibular growth.
  • Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders.
  • Patients with drug or alcohol abuse.
  • Patients with allergies or hypersensitivity to zirconium oxide (ZrO2), yttrium oxide (Y2O3), hafnium dioxide (HfO2), aluminium oxide (Al2O3), and titanium (Grade 4).
  • Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders).
  • Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability.
  • Pregnancy or intention to become pregnant at any point during the study duration.

Furthermore, patients with uncontrolled periodontitis and less than 3 mm of keratinized mucosa at the day of surgery will be excluded from the study. Controlled periodontitis is defined as treated periodontitis with two or less pockets that are < 4 mm in depth or the existence of ≤ 20% bleeding on probing.

If the planned implant position is the second premolar, the adjacent molar must be present. Shortened arches with missing molars are not eligible in such a case.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908177


Contacts
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Contact: Michael A McCaskey, PhD +41619651741 michael.mccaskey@straumann.com
Contact: Julia Dorn, PhD +41619651506 julia.dorn@straumann.com

Locations
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Germany
Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Petra Gierthmühlen, Prof.    +49 211 811 81 42    Petra.Gierthmuehlen@med.uni-duesseldorf.de   
Hong Kong
The University of Hong Kong, Prince Philip Dental Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: Maurizio Tonetti, Prof.    +852 2859 0297    tonetti@hku.hk   
Portugal
Implantology Institute Not yet recruiting
Lisboa, Portugal, 1070-064
Contact: João Caramês, Prof.    +351 217 210 980    md@institutodeimplantologia.pt   
Sponsors and Collaborators
Institut Straumann AG
Factory CRO
DFNet Research Inc.

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Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT03908177     History of Changes
Other Study ID Numbers: CR2017-04
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No