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

NCT02552810 | Completed Results DMC

• 1 other identifier: UValencia_001_Plasma
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endosseous Dental Implant Failure; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  During all the follow-up (5 years)

Secondary Outcomes (5)

• Any Biological or Technical Complications.

  During all the follow-up (5 years)

• Peri-implant Marginal Bone Level Changes (Express in mm).

  At 5 years.

• 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.

  At 5 years.

• Percentage of Patients With Plaque Index

  At 5 years.

• Percentage of Patients With Bleeding on Probing

  At 5 years.

Study Arms (2)

Plasma of Argon

ACTIVE COMPARATOR

Abutment cleaning by plasma of Argon protocol .

Device: Plasma of Argon

Steam clean

ACTIVE COMPARATOR

Abutment cleaning by steam clean device.

Device: Steam clean

Interventions

Steam clean DEVICE

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

Steam clean

Plasma of Argon 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.

Plasma of Argon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Related Publications (1)

• 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.

  PMID: 24191873 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Luigi Canullo
• Organization: University of Valencia

luigicanullo@yahoo.com

+39 347 6201976

Study Officials

• Luigi Canullo

  University of Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical researcher, study adviser

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 17, 2015
• Study Start: January 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2015
• Last Updated: June 17, 2016
• Results First Posted: June 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share