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

NCT05179746 | Unknown

• 1 other identifier: Electrolytic cleaning
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peri-Implantitis

Keywords

treatment of peri-implantitis; electrolytic cleaning

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Microbiological Parameters

  Assessing the change of the microbiological parameters from baseline at 3 months, 6 months

Study Arms (2)

With electrolytic cleaning

ACTIVE COMPARATOR

Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Device: Implants are decontaminated with electrolytic cleaning

Without electrolytic cleaning

PLACEBO COMPARATOR

Mechanical debridement with ultrasonics (plastic tip) and plastic curettes

Device: Implants are decontaminated without electrolytic cleaning

Interventions

Implants are decontaminated with electrolytic cleaning DEVICE

Implants are decontaminated with electrolytic cleaning

With electrolytic cleaning

Implants are decontaminated without electrolytic cleaning DEVICE

Implants are decontaminated without electrolytic cleaning

Without electrolytic cleaning

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• (1) Pregnant, lactating women and non-collaborating patients will be excluded from the study.

Sponsors & Collaborators

• University of Lisbon: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tiago Ribeiro-Amaral, Dr

  University of Lisbon

  PRINCIPAL INVESTIGATOR

• Paulo Macaranhas, PhD

  University of Lisbon

  STUDY DIRECTOR

• Vanessa Rocha Rodrigues, Dr

  University of Lisbon

  STUDY CHAIR

• Susana Noronha, PhD

  University of Lisbon

  STUDY DIRECTOR

Central Study Contacts

Vanessa Rocha Rodrigues, Dr

CONTACT

919950890; vanessa_15_rodrigues@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 5, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share