Mechanical Treatment Peri-Implant Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Mechanical Treatment of Peri-Implant Mucositis -the Effect of Submucosal Instrumentation

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Device: Ultrasonic debridement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallell group two-arm randomised study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical treatment arm + oral hygiene reinforcement<br>Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip. | Device: Ultrasonic debridement<br>* Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)<br>|
| No Intervention: Oral hygiene reinforcement alone<br>Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing (BoP) extent | Reduction in the extent of BoP as measured on six sites per implant | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant sulcus fluid (PISF) biomarkers | Biomarkers sampled at baseline, 3- and 6-months | 6 months | 
| Intraoral digital scan | Volumetric change of soft tissue following peri-implant mucositis treatment | 6 months | 
| Disease resolution | No BoP at any of the six probed sites at 6-month follow-up | 6 months | 
| Severity of BoP | Reduction in the severity of BoP (graded from 0-3) at 6 months | 6 months | 
| Probing pocket depth (PPD) reduction | Reduction in PPD at 6 months | 6 months | 
| Bone level changes | Changes in bone level as assessed by radiographs at baseline and 6-months | 6 months | 
| Onset of peri-implantitis | 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. | 6 months |