Mechanical Treatment Peri-Implant Mucositis

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Device: Ultrasonic debridement

• Registration Number: NCT05664425
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-23
• Study Start: 2023-03-01
• Primary Completion: 2025-02-25
• Study Completion: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical treatment arm + oral hygiene reinforcement	Ultrasonic debridement	Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip.

Primary Outcome Measures

Name	Time	Method
Bleeding on probing (BoP) extent	6 months	Reduction in the extent of BoP as measured on six sites per implant

Secondary Outcome Measures

Name	Time	Method
Peri-implant sulcus fluid (PISF) biomarkers	6 months	Biomarkers sampled at baseline, 3- and 6-months
Intraoral digital scan	6 months	Volumetric change of soft tissue following peri-implant mucositis treatment
Severity of BoP	6 months	Reduction in the severity of BoP (graded from 0-3) at 6 months
Disease resolution	6 months	No BoP at any of the six probed sites at 6-month follow-up
Probing pocket depth (PPD) reduction	6 months	Reduction in PPD at 6 months
Bone level changes	6 months	Changes in bone level as assessed by radiographs at baseline and 6-months
Onset of peri-implantitis	6 months	If peri-implantitis is diagnosed during or following the study, this will be reported. Peri-implantitis is defined as progressive bone loss identified by an increase of PPD changes or bone level changes.

Trial Locations

Locations (1)

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo; 🇳🇴 Oslo, Norway