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

NCT ID: NCT05179746

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-09-01

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.

Conditions

Peri-Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

With electrolytic cleaning

Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Group Type: ACTIVE_COMPARATOR

Implants are decontaminated with electrolytic cleaning

Intervention Type: DEVICE

Implants are decontaminated with electrolytic cleaning

Without electrolytic cleaning

Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Group Type: PLACEBO_COMPARATOR

Implants are decontaminated without electrolytic cleaning

Intervention Type: DEVICE

Implants are decontaminated without electrolytic cleaning

Interventions

Implants are decontaminated with electrolytic cleaning

Implants are decontaminated with electrolytic cleaning

Intervention Type: DEVICE

Implants are decontaminated without electrolytic cleaning

Implants are decontaminated without electrolytic cleaning

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lisbon

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Rocha Rodrigues

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiago Ribeiro-Amaral, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Lisbon

Paulo Macaranhas, PhD

Role: STUDY_DIRECTOR

University of Lisbon

Vanessa Rocha Rodrigues, Dr

Role: STUDY_CHAIR

University of Lisbon

Susana Noronha, PhD

Role: STUDY_DIRECTOR

University of Lisbon

Central Contacts

Vanessa Rocha Rodrigues, Dr

Role: CONTACT

vanessa_15_rodrigues@hotmail.com

919950890 ext. +351

Other Identifiers

Electrolytic cleaning

Identifier Type: -

Identifier Source: org_study_id