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

University of Valencia

Status: Completed

Conditions: Alveolar Bone Loss; Endosseous Dental Implant Failure

Treatments: Device: Steam clean; Device: Plasma of Argon

Study type: Interventional

Funder types: Other

Identifiers

NCT02552810

UValencia_001_Plasma

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Plasma of Argon

Active Comparator group

Description:

Abutment cleaning by plasma of Argon protocol .

Treatment:

Device: Plasma of Argon

Steam clean

Active Comparator group

Description:

Abutment cleaning by steam clean device.

Treatment:

Device: Steam clean