Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a RCT

Dental Implants 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552810
• Other study ID #: UValencia_001_Plasma
• Status: Completed
• Phase: N/A
• First received: September 14, 2015
• Last updated: September 16, 2015
• Start date: January 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• Dental implant placement
Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.
• Second stage surgery
After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.
• Abutment connection
Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).

Device:
• Steam cleaning
Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
• Plasma of Argon
Test group abutments 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

References & Publications (1)

Canullo L, Peñarrocha 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the implants and prostheses (percentage).		During all the follow-up (5 years)	Yes
Secondary	Any biological or technical complications.		During all the follow-up (5 years)	Yes
Secondary	Peri-implant marginal bone level changes (express in mm).		At 1, 2 and 5 years.	Yes
Secondary	Esthetic parameters (VAS score).		At 5 years.	Yes
Secondary	Probing depth	Measured in mm from gingival contour to bone level.	At 5 years.	Yes
Secondary	Bleeding on probing	Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.	At 5 years.	Yes