Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.

Study Overview
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Brief Summary
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Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®). The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of BOP and/or SOP and no further bone loss) at 1 year of follow-up.

Detailed Description
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The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group. The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group. The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.

Official Title
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Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis. A 1-year Randomized Controlled Clinical Trial.

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Implants are decontaminated with electrolytic cleaning
* Device: Implants are decontaminated without electrolytic cleaning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible; Presence of Peri-implantitis; No implant mobility; Treated periodontal disease; No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication). Non-smoker or light smoking status in smokers (<10 cigarettes/day). Exclusion Criteria: (1) Pregnant, lactating women and non-collaborating patients will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With electrolytic cleaning<br>Mechanical debridement with ultrasonics (plastic tip) and plastic curettes | Device: Implants are decontaminated with electrolytic cleaning<br>* Implants are decontaminated with electrolytic cleaning<br>|
| Placebo Comparator: Without electrolytic cleaning<br>Mechanical debridement with ultrasonics (plastic tip) and plastic curettes | Device: Implants are decontaminated without electrolytic cleaning<br>* Implants are decontaminated without electrolytic cleaning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli & Lang, 1994). | Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months | 
| Recession | will be measured as the distance from the free marginal mucosa to the most apical portion of the crown. | Assessing the change of recession from baseline at 3 months, 6 months and 12 months | 
| Clinical attachment level | will be calculated as the sum of PPD and REC (distance from the most apical portion of the crown to the bottom of the periodontal pocket) | Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months | 
| Bleeding on probing | will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008). | Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months | 
| Radiographic Parameters | Radiographic analysis through orthopantomography, periapical intraoral radiographs according to the parallelometric technique (using a silicone bite record so that the radiographs are parallelized and comparable to each other in different timepoints, checking in millimeters the increase or decrease in bone loss). | Assessing the change of the radiographic parameters from baseline at 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Parameters | A sterilized paper tip from the microbiological kit will be introduced in the periimplantitis pocket, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum. | Assessing the change of the microbiological parameters from baseline at 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment of peri-implantitis, electrolytic cleaning