Mechanical Treatment Peri-Implant Mucositis

NCT ID: NCT05664425

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-02-25

Brief Summary

This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.

Conditions

Peri-implant Mucositis

Study Design

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

Study Groups

Mechanical treatment arm + oral hygiene reinforcement

Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip.

Group Type: EXPERIMENTAL

Ultrasonic debridement

Intervention Type: DEVICE

Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)

Oral hygiene reinforcement alone

Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasonic debridement

Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject must be ≥ 20 years
• Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of <2mm from the top of the intraosseous part of the implant is considered as the reference threshold)
• Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus).
• No evidence of occlusal overload
• No cement remnants identified on radiographs or clinically
• Implant-supported fixed restoration inserted at least 6 months before patient enrolment and not interfering with assessment of clinical parameters at more than 3/6 sites
• Periodontally healthy subjects or treated periodontitis (no residual site with PPD ≥ 5 mm)
• Full-mouth plaque (FMPS) and bleeding (FMBS) score ≤ 20%¬¬¬¬¬¬¬ at screening visit
• Non-smokers or light-smokers (<10 cigarettes per day)
• Competent to give consent

Exclusion Criteria

• Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment
• Hematologic disorders
• Pregnant subjects
• Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
• No systemic antibiotic treatment within 3 months prior to intervention

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Anders Verket

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo

Oslo, , Norway

Countries

Norway

Other Identifiers

MechTreatPiM

Identifier Type: -

Identifier Source: org_study_id