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

NCT ID: NCT02552810

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Endosseous Dental Implant Failure; Alveolar Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Plasma of Argon

Abutment cleaning by plasma of Argon protocol .

Group Type: ACTIVE_COMPARATOR

Plasma of Argon

Intervention Type: DEVICE

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.

Steam clean

Abutment cleaning by steam clean device.

Group Type: ACTIVE_COMPARATOR

Steam clean

Intervention Type: DEVICE

Control group: dental implant abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 megapascal (MPa).

Interventions

Steam clean

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

Plasma of Argon

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Luigi Canullo

Clinical researcher, study adviser

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luigi Canullo

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

References

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.

Reference Type: RESULT

PMID: 24191873 (View on PubMed)

Other Identifiers

UValencia_001_Plasma

Identifier Type: -

Identifier Source: org_study_id