Clinical trial NCT05179746: Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.
Official title: Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis. A 1-year Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-Implantitis
Keywords: treatment of peri-implantitis
electrolytic cleaning
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Probing pocket depth
timeFrame: Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months
measure: Recession
timeFrame: Assessing the change of recession from baseline at 3 months, 6 months and 12 months
measure: Clinical attachment level
timeFrame: Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months
measure: Bleeding on probing
timeFrame: Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months
measure: Radiographic Parameters
timeFrame: Assessing the change of the radiographic parameters from baseline at 3 months, 6 months
Secondary outcomes:
measure: Microbiological Parameters
timeFrame: Assessing the change of the microbiological parameters from baseline at 3 months, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Lisbon
name: Tiago Ribeiro-Amaral, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lisbon
name: Paulo Macaranhas, PhD
role: STUDY_DIRECTOR
affiliation: University of Lisbon
name: Vanessa Rocha Rodrigues, Dr
role: STUDY_CHAIR
affiliation: University of Lisbon
name: Susana Noronha, PhD
role: STUDY_DIRECTOR
References: