Mechanical Treatment Peri-Implant Mucositis

Peri-implant Mucositis Clinical Trial

— MechTreatPiM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664425
• Other study ID #: MechTreatPiM
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

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

Locations

Country	Name	City	State
Norway	Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on probing (BoP) extent	Reduction in the extent of BoP as measured on six sites per implant	6 months
Secondary	Peri-implant sulcus fluid (PISF) biomarkers	Biomarkers sampled at baseline, 3- and 6-months	6 months
Secondary	Intraoral digital scan	Volumetric change of soft tissue following peri-implant mucositis treatment	6 months
Secondary	Disease resolution	No BoP at any of the six probed sites at 6-month follow-up	6 months
Secondary	Severity of BoP	Reduction in the severity of BoP (graded from 0-3) at 6 months	6 months
Secondary	Probing pocket depth (PPD) reduction	Reduction in PPD at 6 months	6 months
Secondary	Bone level changes	Changes in bone level as assessed by radiographs at baseline and 6-months	6 months
Secondary	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