Peri-Implantitis
Conditions
Keywords
Peri-implantitis, Electrolytic cleaning, Implant decontamination, Non-surgical treatment
Brief summary
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
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.
Interventions
BEHAVIORALImplant hygiene instructions and removal of the prosthesis
Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis
PROCEDURENon-surgical peri-implantitis treatment /microsurgery
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
PROCEDUREImplant surface decontamination 1(ultrasonic device)
Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
PROCEDUREImplant surface decontamination 2 (air polishing)
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).
PROCEDUREImplant surface decontamination 3 (electrolytic cleaning)
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.
DRUGAntibiotic treatment (Metronidazole)
Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
PROCEDUREModification and polishing of the prosthesis
If necessary, modification and polishing of the prosthesis to make it cleanable.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant disease resolution at 6 month | 6 months | Probing depth \< 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz & Chapple 2012) |
| Peri-implant disease resolution at 12 month | 12 months | Probing depth \< 5 mm, with absence of bleeding or suppuration and no additional |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant plaque index at 6 months | 6 months | Implant plaque index (PI) (at 6 sites/implant)(+/-). |
| Implant plaque index at 12 months | 12 months | Implant plaque index (PI) (at 6 sites/implant)(+/-). |
| Peri-implant probing depth at 6 months | 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). |
| Peri-implant probing depth at 12 months | 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). |
| Bleeding on probing at 6 months | 6 months | Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-). |
| Bleeding on probing at 12 months | 12 months | Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-). |
| Suppuration at 6 months | 6 months | Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) nice, regular, unpleasant, very unpleasant). |
| Suppuration at 12 months | 12 months | Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) |
| Implant survival rate at 6 months | 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. |
| Recession of the mucosal margin at 12 months | 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). |
| Bone loss at 6 months | 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. |
| Bone loss at 12 months | 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. |
| Patient centred outcomes of the electrolytic cleaning after 6 months | 6 months | Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). |
| Patient centred outcomes of the electrolytic cleaning after 12 months | 12 months | Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). |
| Overall satisfaction after 6 months | 6 months | Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). |
| Overall satisfaction after 12 months | 12 months | Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant). |
| Recession of the mucosal margin at 6 months | 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). |
| Implant survival rate at 12 months | 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. |
Countries
Spain
Outcome results
None listed