Trial Outcomes & Findings for Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a Randomized Clinical Trial (NCT NCT02552810)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

During all the follow-up (5 years)

Results posted on

2016-06-17

Participant Flow

Eligible patients who met the inclusion criteria were asked to participate and were enrolled in consecutive order between January and September 2010 at the Department of Oral Surgery, University of Valencia.

Participant milestones

Participant milestones
Measure	Plasma of Argon Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=15 Participants Test group abutments, after milled, polished and cleaned for 30s in the same laboratory, underwent argon plasma treatment (75 W of power and -10 MPa of pressure for 12 minutes at room temperature) in a plasma reactor8 located in the same clinic but in a different room. All the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.	Control Group n=15 Participants Control group were cleaned by steam for 30s 7 by the dental technician in the laboratory located in the same clinic, but in a different room, immediately before delivering to the clinician. Then all the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.	Total n=30 Participants Total of all reporting groups
Age, Continuous	56.3 years n=5 Participants	60.1 years n=7 Participants	58.4 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Spain	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: During all the follow-up (5 years)

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.

Outcome measures

Outcome measures
Measure	Plasma of Argon n=15 Participants Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean n=15 Participants Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
Success Rate of the Implants and Prostheses (Participants).	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: During all the follow-up (5 years)

Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.

Outcome measures

Outcome measures
Measure	Plasma of Argon n=15 Participants Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean n=15 Participants Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
Any Biological or Technical Complications.	0 participants	0 participants

SECONDARY outcome

Timeframe: At 5 years.

At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.

Outcome measures

Outcome measures
Measure	Plasma of Argon n=15 Participants Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean n=15 Participants Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
Peri-implant Marginal Bone Level Changes (Express in mm).	0.21 mm Standard Deviation 0.21	0.65 mm Standard Deviation 0.36

SECONDARY outcome

Timeframe: At 5 years.

A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline. The full procedure was published in: Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research \[Internet\]. 2009 Apr;20(4):414-20.

Outcome measures

Outcome measures
Measure	Plasma of Argon n=15 Participants Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean n=15 Participants Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
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. REC	0.58 mm Standard Deviation 0.66	0.22 mm Standard Deviation 0.35
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. PH	0.48 mm Standard Deviation 0.40	0.39 mm Standard Deviation 0.31

SECONDARY outcome

Timeframe: At 5 years.

Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.

Outcome measures

Outcome measures
Measure	Plasma of Argon n=15 Participants Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean n=15 Participants Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
Percentage of Patients With Plaque Index	13.3 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: At 5 years.

Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.

Outcome measures

Outcome measures
Measure	Plasma of Argon n=15 Participants Abutment cleaning by plasma of Argon protocol . 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). 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.	Steam Clean n=15 Participants Cleaning protocol by steaming. 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). Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa.
Percentage of Patients With Bleeding on Probing	6.6 percentage of participants	20 percentage of participants

Adverse Events

Plasma of Argon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Steam Clean

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Luigi Canullo

University of Valencia

Phone: +39 347 6201976

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place