Peri-Implantitis Clinical Trial
Official title:
Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis. A 1-year Randomized Controlled Clinical Trial.
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Lisbon |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Probing pocket depth | Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli & Lang, 1994). | Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months | |
Primary | Recession | will be measured as the distance from the free marginal mucosa to the most apical portion of the crown. | Assessing the change of recession from baseline at 3 months, 6 months and 12 months | |
Primary | Clinical attachment level | 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) | Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months | |
Primary | Bleeding on probing | will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008). | Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months | |
Primary | Radiographic Parameters | 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). | Assessing the change of the radiographic parameters from baseline at 3 months, 6 months | |
Secondary | Microbiological Parameters | 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. | Assessing the change of the microbiological parameters from baseline at 3 months, 6 months |
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