Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Device: Implants are decontaminated with electrolytic cleaning; Device: Implants are decontaminated without electrolytic cleaning

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Rocha Rodrigues, Dr; Phone Number: +351 919950890; Email: vanessa_15_rodrigues@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: With electrolytic cleaning; Mechanical debridement with ultrasonics (plastic tip) and plastic curettes	Device: Implants are decontaminated with electrolytic cleaning; Implants are decontaminated with electrolytic cleaning
PLACEBO_COMPARATOR: Without electrolytic cleaning; Mechanical debridement with ultrasonics (plastic tip) and plastic curettes	Device: Implants are decontaminated without electrolytic cleaning; Implants are decontaminated without electrolytic cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Lisbon
• Investigators: Principal Investigator: Tiago Ribeiro-Amaral, Dr, University of Lisbon; Study Director: Paulo Macaranhas, PhD, University of Lisbon; Study Chair: Vanessa Rocha Rodrigues, Dr, University of Lisbon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (ACTUAL): January 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: treatment of peri-implantitis; electrolytic cleaning
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: Electrolytic cleaning

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No