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
About this trial
This is an interventional treatment trial for Endosseous Dental Implant Failure
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.
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
NCT ID
NCT02552810
First Posted
September 14, 2015
Last Updated
May 10, 2016
Sponsor
University of Valencia
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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