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Trial record 79 of 119 for:    ZIRCONIUM

Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss

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ClinicalTrials.gov Identifier: NCT01961635
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Andre Chen, Instituto de Implantologia

Brief Summary:
In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?

Condition or disease Intervention/treatment Phase
Bone Loss Inflammation Device: dental implants Device: Zirconia abutments Device: Titanium Abutments Device: cad-cam acrylic abutments Procedure: Subcrestal Device: platform-switch Procedure: one-time one-abutment Procedure: Torque 20 n/cm2 Not Applicable

Detailed Description:
Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial
Study Start Date : January 2016
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Arm Intervention/treatment
Experimental: Zirconia Abutments
Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
Device: dental implants
place implant according fabricant guidelines, 2mm sub-crestally
Other Names:
  • T3 - Biomet 3I Implants
  • Platform-Switch 4.1
  • Abutment Diameter 3.25

Device: Zirconia abutments
place zirconia abutment on the day of implant placement
Other Names:
  • Zirconia cad-cam abutment
  • 3.25 Abutment connection

Procedure: Subcrestal
place implant 2mm below crestal bone

Device: platform-switch
abutment platform is narrow than implant diameter

Procedure: one-time one-abutment
place the final abutment on the day of surgery and not remove it
Other Names:
  • one time abutment
  • final abutment on the day of surgery

Procedure: Torque 20 n/cm2
the amount of torque applied to the abutment
Other Name: manual torque

Experimental: Titanium Abutments
Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
Device: dental implants
place implant according fabricant guidelines, 2mm sub-crestally
Other Names:
  • T3 - Biomet 3I Implants
  • Platform-Switch 4.1
  • Abutment Diameter 3.25

Device: Titanium Abutments
place titanium abutment on the day of implant placement
Other Names:
  • Titanium Encode - biomet 3I Implants
  • 3,25 abutment connection

Procedure: Subcrestal
place implant 2mm below crestal bone

Device: platform-switch
abutment platform is narrow than implant diameter

Procedure: one-time one-abutment
place the final abutment on the day of surgery and not remove it
Other Names:
  • one time abutment
  • final abutment on the day of surgery

Procedure: Torque 20 n/cm2
the amount of torque applied to the abutment
Other Name: manual torque

Experimental: Cad-Cam Acrylic abutments
Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
Device: dental implants
place implant according fabricant guidelines, 2mm sub-crestally
Other Names:
  • T3 - Biomet 3I Implants
  • Platform-Switch 4.1
  • Abutment Diameter 3.25

Device: cad-cam acrylic abutments
place cad-cam acrylic abutment on the day of implant placement
Other Names:
  • Cad-cam acrylic abutment
  • 3.25 platform

Procedure: Subcrestal
place implant 2mm below crestal bone

Device: platform-switch
abutment platform is narrow than implant diameter

Procedure: one-time one-abutment
place the final abutment on the day of surgery and not remove it
Other Names:
  • one time abutment
  • final abutment on the day of surgery

Procedure: Torque 20 n/cm2
the amount of torque applied to the abutment
Other Name: manual torque




Primary Outcome Measures :
  1. Gingival Inflammatory Changes from baseline to 12 weeks [ Time Frame: Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks ]
    measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic


Secondary Outcome Measures :
  1. Marginal Bone Loss [ Time Frame: measured at 12 weeks post-implant installation ]
    Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic

  2. Gingival height [ Time Frame: 12 weeks post-implant installation ]
    measure with periodontal probe distance from implant platform to the most coronal point of gingival margin mesial, distal, buccal and lingual,in zirconia,titanium, acrylic, and cad-cam acrylic

  3. Osseointegration [ Time Frame: 12 weeks post-implant installation ]
    compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments

  4. Height from gingiva to abutment [ Time Frame: 12 weeks post implant installation ]
    height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments



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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:

  • Single unit implant rehabilitation
  • Maxilla and mandible
  • Must accept treatment plan
  • Must sign informed consent
  • dental extraction performed at least 3 month prior
  • Must have at least 6 mm of residual bone
  • Absence of oral lesions
  • keratinized tissue must be present

Exclusion Criteria:

  • If smoking and/or other drug addiction is present
  • If local anesthetic allergy is present
  • Patient subjected to chemical or radiotherapy
  • if Hepatic disease is present
  • If immunodepression is present
  • If Pregnancy is present
  • If Diabetes is present
  • If Heart disease is present

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): NCT01961635


Locations
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Portugal
Faculdade de Medicina Dentária de Lisboa
Lisbon, Portugal, 1500-662
Sponsors and Collaborators
Instituto de Implantologia
Investigators
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Principal Investigator: João Caramês, Phd Faculdade de Medicina Dentária de Lisboa
Study Director: André Chen Chen, Msc Faculdade de Medicina Dentária de Lisboa
Study Chair: Elena Cervino, Msc Instituto de Implantologia
Study Chair: Helena Francisco, Phd Faculdade de Medicina Dentária de Lisboa

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Responsible Party: Andre Chen, Msc, Instituto de Implantologia
ClinicalTrials.gov Identifier: NCT01961635     History of Changes
Other Study ID Numbers: II-01
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andre Chen, Instituto de Implantologia:
Dental Implants
Zirconia Abutments
Titanium abutments
Acrylic abutments
Gingival Healing
Inflammation
Bone loss
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors