Peri-Implantitis
Conditions
Keywords
treatment of peri-implantitis, electrolytic cleaning
Brief summary
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
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.
Interventions
DEVICEImplants are decontaminated with electrolytic cleaning
Implants are decontaminated with electrolytic cleaning
DEVICEImplants are decontaminated without electrolytic cleaning
Implants are decontaminated without electrolytic cleaning
Sponsors
University of Lisbon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible; 2. Presence of Peri-implantitis; 3. No implant mobility; 4. Treated periodontal disease; 5. No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication). 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months | Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli & Lang, 1994). |
| Recession | Assessing the change of recession from baseline at 3 months, 6 months and 12 months | will be measured as the distance from the free marginal mucosa to the most apical portion of the crown. |
| Clinical attachment level | Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months | 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) |
| Bleeding on probing | Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months | will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008). |
| Radiographic Parameters | Assessing the change of the radiographic parameters from baseline at 3 months, 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological Parameters | Assessing the change of the microbiological parameters from baseline at 3 months, 6 months | 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. |
Contacts
Primary ContactVanessa Rocha Rodrigues, Dr
Outcome results
None listed