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

Universidade de Lisboa

Status: Not yet enrolling

Conditions: Peri-Implantitis

Treatments: Device: Implants are decontaminated with electrolytic cleaning; Device: Implants are decontaminated without electrolytic cleaning

Study type: Interventional

Funder types: Other

Identifiers

NCT05179746

Electrolytic cleaning

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

With electrolytic cleaning

Active Comparator group

Description:

Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Treatment:

Device: Implants are decontaminated with electrolytic cleaning

Without electrolytic cleaning

Placebo Comparator group

Description:

Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Treatment:

Device: Implants are decontaminated without electrolytic cleaning