Non-surgical Electrolytic Cleaning Peri-implantitis

Study Overview
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Brief Summary
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Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.

Detailed Description
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Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do. Therapeutic success is defined as as a composite index (Sanz & Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth < 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration. This study will be carried out in the following centers: Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain) CEOSA-Madrid Private Dental Centre After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at: 3 months. 6 months. 12 months. After non-surgical therapy, patients will be included in a strict peri-implant maintenance therapy program to avoid re-contamination of the affected implants. Removal of biofilm with air polishing without anaesthesia and oral hygiene instruction reinforcement will be performed at: 3 months, 6 months, 9 months and 12 months.

Official Title
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Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Behavioral: Implant hygiene instructions and removal of the prosthesis
* Procedure: Non-surgical peri-implantitis treatment /microsurgery
* Procedure: Implant surface decontamination 1(ultrasonic device)
* Procedure: Implant surface decontamination 2 (air polishing)
* Procedure: Implant surface decontamination 3 (electrolytic cleaning)
* Drug: Antibiotic treatment (Metronidazole)
* Procedure: Modification and polishing of the prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age > 18 years. Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018) Peri-implant bone loss < 2/3 History of treated periodontal diseases (Caton 2018). Screw retained prosthesis that can be easily unscrewed. Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly. Absence of implant mobility Exclusion Criteria: Systemic exclusion criteria Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation) Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism. History of leukocyte dysfunction and deficiencies. History of neoplastic disease requiring the use of radiation or chemotherapy. Patients with chronic renal failure requiring dialysis. Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications. History of uncontrolled endocrine disorders: hypothyroidism or diabetes. Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning. Alcoholism or drug abuse. History of immunodeficiency syndromes. Tobacco consumption (smoking more than 10 cigarettes per day) Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment Local exclusion criteria Mucosal diseases such as erosive lichen planus in the area to be treated. History of local irradiation therapy. Implants with peri-implant bone loss beyond 2/3 of the implant length

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-surgical electrolytic cleaning<br>Implant hygiene instructions and removal of the prosthesis Local anaesthesia Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss). Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA). Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length. Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day). If necessary, modification and polishing of the prosthesis to make it cleanable. | Behavioral: Implant hygiene instructions and removal of the prosthesis<br>* Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis<br>Procedure: Non-surgical peri-implantitis treatment /microsurgery<br>* Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) after applying local anestesia<br>Procedure: Implant surface decontamination 1(ultrasonic device)<br>* Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).<br>Procedure: Implant surface decontamination 2 (air polishing)<br>* Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).<br>Procedure: Implant surface decontamination 3 (electrolytic cleaning)<br>* Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.<br>Drug: Antibiotic treatment (Metronidazole)<br>* Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).<br>* Other names: Metronidazole;Procedure: Modification and polishing of the prosthesis<br>* If necessary, modification and polishing of the prosthesis to make it cleanable.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant disease resolution at 6 month | Probing depth < 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz & Chapple 2012) | 6 months | 
| Peri-implant disease resolution at 12 month | Probing depth < 5 mm, with absence of bleeding or suppuration and no additional | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rate at 6 months | Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection. | 6 months | 
| Implant survival rate at 12 months | Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection. | 12 months | 
| Implant plaque index at 6 months | Implant plaque index (PI) (at 6 sites/implant)(+/-). | 6 months | 
| Implant plaque index at 12 months | Implant plaque index (PI) (at 6 sites/implant)(+/-). | 12 months | 
| Peri-implant probing depth at 6 months | Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany). | 6 months | 
| Peri-implant probing depth at 12 months | Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany). | 12 months | 
| Bleeding on probing at 6 months | Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-). | 6 months | 
| Bleeding on probing at 12 months | Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-). | 12 months | 
| Suppuration at 6 months | Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) nice, regular, unpleasant, very unpleasant). | 6 months | 
| Suppuration at 12 months | Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) | 12 months | 
| Recession of the mucosal margin at 6 months | Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany). | 6 months | 
| Recession of the mucosal margin at 12 months | Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany). | 12 months | 
| Bone loss at 6 months | Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures. Digital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length. | 6 months | 
| Bone loss at 12 months | Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures. Digital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length. | 12 months | 
| Patient centred outcomes of the electrolytic cleaning after 6 months | Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). | 6 months | 
| Patient centred outcomes of the electrolytic cleaning after 12 months | Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). | 12 months | 
| Overall satisfaction after 6 months | Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). | 6 months | 
| Overall satisfaction after 12 months | Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implantitis, Electrolytic cleaning, Implant decontamination, Non-surgical treatment