search
Back to results

Adjunctive 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
University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring treatment of peri-implantitis, electrolytic cleaning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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

    First Posted
    December 3, 2021
    Last Updated
    June 22, 2022
    Sponsor
    University of Lisbon
    search

    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.

    We'll reach out to this number within 24 hrs