Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing

NCT05811390 | Completed

• 1 other identifier: Periimplantitis treatment
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.

Conditions

Periimplantitis

Outcome Measures

Primary Outcomes (1)

• Change in probing pocket depth

  The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).

  0, 3, 6, 12 months

Secondary Outcomes (5)

• PROMS

  0 months

• Change in alveolar bone level

  0,12 months

• Change in gingival recession

  0, 3, 6, 12 months

• Bleeding on probing

  0, 3, 6, 12 months

• Implant survival rate

  0, 12 months

Study Arms (2)

erythritol jet (EMS)

EXPERIMENTAL

An erythritol jet (Perioflow from EMS) will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.

Device: erythritol jet

Manual instrumentation

ACTIVE COMPARATOR

An ultrasonic handpiece will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.

Device: Manual instrumentation

Interventions

erythritol jet DEVICE

Use of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole

erythritol jet (EMS)

Manual instrumentation DEVICE

Use of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole

Manual instrumentation

Eligibility Criteria

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

You may qualify if:

• At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown
• Patients of legal age (≥18 years old)

You may not qualify if:

• Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c \> 7% or \>53 mmol/mol)
• Pregnant or lactating patients
• Severe smoking (\>20 cigarettes/day)
• Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)
• Patients who missed study control visits
• Patients who have received systemic antibiotic therapy in the last 2 months
• Patients with allergies to any of the components used in the study, namely to erythritol
• Implants that have previously undergone surgical treatment for peri-implantitis
• Implants with bone loss greater than 2/3 of their length and/or mobility

Sponsors & Collaborators

• Universidade do Porto: lead
• EMS: collaborator

Study Sites (1)

Faculty of Dentistry at the University of OPorto

Porto, Porto District, 4200-393, Portugal

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ana Isabel Moreira

  Faculdade de Medicina Dentária da Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 13, 2023
• Study Start: October 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)