Clinical trial NCT02552810: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endosseous Dental Implant Failure
Alveolar Bone Loss
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success Rate of the Implants and Prostheses (Participants).
timeFrame: During all the follow-up (5 years)
Secondary outcomes:
measure: Any Biological or Technical Complications.
timeFrame: During all the follow-up (5 years)
measure: Peri-implant Marginal Bone Level Changes (Express in mm).
timeFrame: At 5 years.
measure: 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.
timeFrame: At 5 years.
measure: Percentage of Patients With Plaque Index
timeFrame: At 5 years.
measure: Percentage of Patients With Bleeding on Probing
timeFrame: At 5 years.
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Luigi Canullo
role: PRINCIPAL_INVESTIGATOR
References:
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.