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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.
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:
After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-surgical electrolytic cleaning | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant hygiene instructions and removal of the prosthesis | Behavioral | Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Systemic exclusion criteria
Local exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz Alonso | University Complutense Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana Carrillo de Albornoz | Madrid | 28040 | Spain |
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| Non-surgical peri-implantitis treatment /microsurgery | Procedure | 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 |
|
| Implant surface decontamination 1(ultrasonic device) | Procedure | Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss). |
|
| Implant surface decontamination 2 (air polishing) | Procedure | 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). |
|
| Implant surface decontamination 3 (electrolytic cleaning) | Procedure | 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) | Drug | Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day). |
|
|
| Modification and polishing of the prosthesis | Procedure | If necessary, modification and polishing of the prosthesis to make it cleanable. |
|
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 |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008866 | Microsurgery |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D008846 | Micromanipulation |
| D008919 | Investigative Techniques |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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