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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis
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
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.
Ana Carrillo de Albornoz
Madrid, Spain
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)
Time frame: 6 months
Peri-implant disease resolution at 12 month
Probing depth \< 5 mm, with absence of bleeding or suppuration and no additional
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
Implant plaque index at 6 months
Implant plaque index (PI) (at 6 sites/implant)(+/-).
Time frame: 6 months
Implant plaque index at 12 months
Implant plaque index (PI) (at 6 sites/implant)(+/-).
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Bleeding on probing at 6 months
Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).
Time frame: 6 months
Bleeding on probing at 12 months
Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).
Time frame: 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).
Time frame: 6 months
Suppuration at 12 months
Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Overall satisfaction after 6 months
Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).
Time frame: 6 months
Overall satisfaction after 12 months
Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).
Time frame: 12 months
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