Back to resultsAdjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.
Primary Purpose
Peri-Implantitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implants are decontaminated with electrolytic cleaning
Implants are decontaminated without electrolytic cleaning
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring treatment of peri-implantitis, electrolytic cleaning
Eligibility Criteria
Inclusion Criteria:
- Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible;
- Presence of Peri-implantitis;
- No implant mobility;
- Treated periodontal disease;
- No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication).
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
With electrolytic cleaning
Without electrolytic cleaning
Arm Description
Mechanical debridement with ultrasonics (plastic tip) and plastic curettes
Mechanical debridement with ultrasonics (plastic tip) and plastic curettes
Outcomes
Primary Outcome Measures
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).
Recession
will be measured as the distance from the free marginal mucosa to the most apical portion of the crown.
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)
Bleeding on probing
will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008).
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05179746
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lisbon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
treatment of peri-implantitis, electrolytic cleaning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With electrolytic cleaning
Arm Type
Active Comparator
Arm Description
Mechanical debridement with ultrasonics (plastic tip) and plastic curettes
Arm Title
Without electrolytic cleaning
Arm Type
Placebo Comparator
Arm Description
Mechanical debridement with ultrasonics (plastic tip) and plastic curettes
Intervention Type
Device
Intervention Name(s)
Implants are decontaminated with electrolytic cleaning
Intervention Description
Implants are decontaminated with electrolytic cleaning
Intervention Type
Device
Intervention Name(s)
Implants are decontaminated without electrolytic cleaning
Intervention Description
Implants are decontaminated without electrolytic cleaning
Primary Outcome Measure Information:
Title
Probing pocket depth
Description
Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli & Lang, 1994).
Time Frame
Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months
Title
Recession
Description
will be measured as the distance from the free marginal mucosa to the most apical portion of the crown.
Time Frame
Assessing the change of recession from baseline at 3 months, 6 months and 12 months
Title
Clinical attachment level
Description
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)
Time Frame
Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months
Title
Bleeding on probing
Description
will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008).
Time Frame
Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months
Title
Radiographic Parameters
Description
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).
Time Frame
Assessing the change of the radiographic parameters from baseline at 3 months, 6 months
Secondary Outcome Measure Information:
Title
Microbiological Parameters
Description
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.
Time Frame
Assessing the change of the microbiological parameters from baseline at 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible;
Presence of Peri-implantitis;
No implant mobility;
Treated periodontal disease;
No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Rocha Rodrigues, Dr
Phone
919950890
Ext
+351
Email
vanessa_15_rodrigues@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiago Ribeiro-Amaral, Dr
Organizational Affiliation
University of Lisbon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo Macaranhas, PhD
Organizational Affiliation
University of Lisbon
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vanessa Rocha Rodrigues, Dr
Organizational Affiliation
University of Lisbon
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susana Noronha, PhD
Organizational Affiliation
University of Lisbon
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.
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