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Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a Randomized Clinical Trial

Primary Purpose

Endosseous Dental Implant Failure, Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Steam clean
Plasma of Argon
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endosseous Dental Implant Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18 years or older, previously treated for periodontal disease according to a comprehensive treatment strategy,25 requiring a single implant-supported restoration in the anterior maxilla or premolar region with the presence of mesial and distal tooth.
  • Bone crest allowing the insertion of a 4 mm platform implant without further bone augmentation procedures and with thin (≤ 1 mm) gingival biotype, measured by previously reported protocol.

Exclusion Criteria:

  • no relevant medical conditions;
  • non-smoker or smoking ≤ 10 cigarettes/day;
  • plaque Index and bleeding on probing ≤ 25 %;
  • impossibility of follow-up for 5 years after prosthetic loading;
  • pregnant and lactating patients;
  • patients with a history of bisphosphonate therapy;
  • presence of sites with acute infections.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Plasma of Argon

    Steam clean

    Arm Description

    Abutment cleaning by plasma of Argon protocol .

    Abutment cleaning by steam clean device.

    Outcomes

    Primary Outcome Measures

    Success Rate of the Implants and Prostheses (Participants).
    An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed. A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis.

    Secondary Outcome Measures

    Any Biological or Technical Complications.
    Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.
    Peri-implant Marginal Bone Level Changes (Express in mm).
    At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.
    Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.
    A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline. The full procedure was published in: Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research [Internet]. 2009 Apr;20(4):414-20.
    Percentage of Patients With Plaque Index
    Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.
    Percentage of Patients With Bleeding on Probing
    Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.

    Full Information

    First Posted
    September 14, 2015
    Last Updated
    May 10, 2016
    Sponsor
    University of Valencia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02552810
    Brief Title
    Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a Randomized Clinical Trial
    Official Title
    Effect of Plasma of Argon Cleaning on Implant Abutments in Patients With a History of Periodontal Disease and Thin Biotype: Five Years Post-loading Results of a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Valencia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Contamination of implant abutments could potentially influence the peri-implant tissue inflammatory response. The aim of the present study was to assess the radiographic bone changes around customized, platform switched, abutments placed according to the "one-abutment-one-time" protocol, with and without plasma of argon cleaning treatment.
    Detailed Description
    After technical procedures, presence of contaminants (mostly Titanium wear micro-particles, Carbon and Aluminum traces due to lubricant used during customization) on the whole abutment surface, the internal connection and the screw can be found, even after the usually cleaning steps (steaming). Such debris, present at titanium/connective-bone tissues interface (gingival portion of the abutment), could directly or indirectly deleteriously influence the inflammatory response on the peri-implant tissues. Plasma of Argon cleaning treatment was demonstrated to have a double effect on titanium abutments: removal of pollutions following customization and increase of cell adhesion. Additionally, Plasma of Argon demonstrated very potent anti-biofilm activity. This prospective, match paired, triple-blinded randomized controlled trial was aimed to test if plasma treatment of customized abutments can affect radiographic peri-implant marginal bone level changes after 5 years of prosthetic loading.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endosseous Dental Implant Failure, Alveolar Bone Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Plasma of Argon
    Arm Type
    Active Comparator
    Arm Description
    Abutment cleaning by plasma of Argon protocol .
    Arm Title
    Steam clean
    Arm Type
    Active Comparator
    Arm Description
    Abutment cleaning by steam clean device.
    Intervention Type
    Device
    Intervention Name(s)
    Steam clean
    Intervention Description
    Control group: dental implant abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 megapascal (MPa).
    Intervention Type
    Device
    Intervention Name(s)
    Plasma of Argon
    Intervention Description
    Test group: dental implant underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes.
    Primary Outcome Measure Information:
    Title
    Success Rate of the Implants and Prostheses (Participants).
    Description
    An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed. A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis.
    Time Frame
    During all the follow-up (5 years)
    Secondary Outcome Measure Information:
    Title
    Any Biological or Technical Complications.
    Description
    Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.
    Time Frame
    During all the follow-up (5 years)
    Title
    Peri-implant Marginal Bone Level Changes (Express in mm).
    Description
    At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.
    Time Frame
    At 5 years.
    Title
    Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.
    Description
    A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline. The full procedure was published in: Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research [Internet]. 2009 Apr;20(4):414-20.
    Time Frame
    At 5 years.
    Title
    Percentage of Patients With Plaque Index
    Description
    Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.
    Time Frame
    At 5 years.
    Title
    Percentage of Patients With Bleeding on Probing
    Description
    Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.
    Time Frame
    At 5 years.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 years or older, previously treated for periodontal disease according to a comprehensive treatment strategy,25 requiring a single implant-supported restoration in the anterior maxilla or premolar region with the presence of mesial and distal tooth. Bone crest allowing the insertion of a 4 mm platform implant without further bone augmentation procedures and with thin (≤ 1 mm) gingival biotype, measured by previously reported protocol. Exclusion Criteria: no relevant medical conditions; non-smoker or smoking ≤ 10 cigarettes/day; plaque Index and bleeding on probing ≤ 25 %; impossibility of follow-up for 5 years after prosthetic loading; pregnant and lactating patients; patients with a history of bisphosphonate therapy; presence of sites with acute infections.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luigi Canullo
    Organizational Affiliation
    University of Valencia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24191873
    Citation
    Canullo L, Penarrocha D, Clementini M, Iannello G, Micarelli C. Impact of plasma of argon cleaning treatment on implant abutments in patients with a history of periodontal disease and thin biotype: radiographic results at 24-month follow-up of a RCT. Clin Oral Implants Res. 2015;26(1):8-14. doi: 10.1111/clr.12290. Epub 2013 Nov 6.
    Results Reference
    result

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    Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a Randomized Clinical Trial

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