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

Not Applicable

Not yet recruiting

• Conditions: Peri-Implantitis
• Interventions: Device: Implants are decontaminated without electrolytic cleaning; Device: Implants are decontaminated with electrolytic cleaning

• Registration Number: NCT05179746
• Lead Sponsor: University of Lisbon

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.

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24
• Study Start: 2022-10-01
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without electrolytic cleaning	Implants are decontaminated without electrolytic cleaning	Mechanical debridement with ultrasonics (plastic tip) and plastic curettes
With electrolytic cleaning	Implants are decontaminated with electrolytic cleaning	Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Primary Outcome Measures

Name	Time	Method
Probing pocket depth	Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months	Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli \& Lang, 1994).
Bleeding on probing	Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months	will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008).
Clinical attachment level	Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months	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)
Recession	Assessing the change of recession from baseline at 3 months, 6 months and 12 months	will be measured as the distance from the free marginal mucosa to the most apical portion of the crown.
Radiographic Parameters	Assessing the change of the radiographic parameters from baseline at 3 months, 6 months	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

Name	Time	Method
Microbiological Parameters	Assessing the change of the microbiological parameters from baseline at 3 months, 6 months	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.