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

Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periimplantitis
• Intervention / Treatment: Device: erythritol jet; Device: Manual instrumentation

Detailed Description

To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • OPorto, Portugal, 4200-393
    • Faculty of Dentistry at the University of OPorto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erythritol jet (EMS); An erythritol jet (Perioflow from EMS) will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.	Device: erythritol jet; Use of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole
Active Comparator: Manual instrumentation; An ultrasonic handpiece will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.	Device: Manual instrumentation; Use of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMS	Patient reported outcomes reported on a visual analog scale from 0 (no pain) to 10 (maximum pain).	0 months
Change in alveolar bone level	Radiographically measured alveolar bone level from the alveolar crest to the implant's neck, mesially and distally (measured in millimetres).	0,12 months
Change in gingival recession	Gingival recession measured at six points per implant with a periodontal probe, from the cementum-enamel junction to the bottom of the probable pocket (measured in millimetres).	0, 3, 6, 12 months
Bleeding on probing	Bleeding on probing (in percentage) assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per implant using one (1) and zero (0) for presence or absence, respectively.	0, 3, 6, 12 months
Implant survival rate	Percentage of implants that survived after 1 year follow-up (implants that remain in the patient's mouth after 1 year).	0, 12 months

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: EMS
• Investigators: Principal Investigator: Ana Isabel Moreira, Faculdade De Medicina Dentaria da Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis; Vasodilator Agents; Erythritol
• Other Study ID Numbers: Periimplantitis treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No