Endosseous Dental Implant FailureNCT02552810
Plasma of Argon Cleaning on Implant Abutments: 5-year Results of a Randomized Clinical Trial
A study testing Steam clean and Plasma of Argon in people with Endosseous Dental Implant Failure and Alveolar Bone Loss, run by University of Valencia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endosseous Dental Implant Failure, Alveolar Bone Loss
- What is being tested?
- Steam clean and Plasma of Argon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Being tested
- Steam clean, Plasma of Argon
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steam cleanDevice
Control group: dental implant abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 megapascal (MPa).
Plasma of ArgonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Plasma of Argon | Active comparator | Abutment cleaning by plasma of Argon protocol . Receives: Device: Plasma of Argon |
| Steam clean | Active comparator | Abutment cleaning by steam clean device. Receives: Device: Steam clean |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During all the follow-up (5 years)
Secondary outcomes (5)
Any Biological or Technical Complications.
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.
Measured: During all the follow-up (5 years)
Peri-implant Marginal Bone Level Changes (Express in mm).
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.
Measured: 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.
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.
Measured: At 5 years.
Percentage of Patients With Plaque Index
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.
Measured: At 5 years.
Percentage of Patients With Bleeding on Probing
Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.
Measured: At 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endosseous Dental Implant FailureStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Canullo, University of Valencia
- Investigators
- Luigi Canullo, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552810
- Sponsor's protocol ID
- UValencia_001_Plasma
- Status last verified
- May 2016
- First submitted
- 14 Sep 2015
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24191873
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02552810
- Acronym / sponsor ID
- UValencia_001_Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma of Argon | Active comparator | Device: Plasma of ArgonAbutment cleaning by plasma of Argon protocol . |
| Steam clean | Active comparator | Device: Steam cleanAbutment cleaning by steam clean device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steam cleanControl group: dental implant abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 megapascal (MPa). | Device | Steam clean |
| Plasma of ArgonTest 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. | Device | Plasma of Argon |
Primary outcome
Success Rate of the Implants and Prostheses (Participants).
Time frame: 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.
5 secondary outcomes
Any Biological or Technical Complications.
Time frame: During all the follow-up (5 years)
Peri-implant Marginal Bone Level Changes (Express in mm).
Time frame: 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.
Time frame: At 5 years.
Percentage of Patients With Plaque Index
Time frame: At 5 years.
Percentage of Patients With Bleeding on Probing
Time frame: At 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24191873Canullo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Canullo principal investigator
University of Valencia
Questions about this trial
What is this clinical trial studying?
A study testing Steam clean and Plasma of Argon in people with Endosseous Dental Implant Failure and Alveolar Bone Loss, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of the Implants and Prostheses (Participants). (time frame: During all the follow-up (5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.