Mechanical Treatment Peri-Implant Mucositis (MechTreatPiM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Device: Ultrasonic debridement

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0455
    • Recruiting
    • Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
    • Contact: Anders Verket, PhD; Phone Number: +47 93667661; Email: anderver@odont.uio.no
    • Contact: Odd Koldsland, PhD; Phone Number: +47 93098618; Email: oddcko@odont.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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: Mechanical treatment arm + oral hygiene reinforcement; Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip.	Device: Ultrasonic debridement; Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)
No Intervention: Oral hygiene reinforcement alone; Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): February 20, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: MechTreatPiM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available for other researchers upon reasonable request and as long as in accordance with ethical committee and national GDPR rules.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No