Mechanical Treatment Peri-Implant Mucositis

NCT05664425 | Completed

• 1 other identifier: MechTreatPiM
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing (BoP) extent

  Reduction in the extent of BoP as measured on six sites per implant

  6 months

Secondary Outcomes (7)

• Peri-implant sulcus fluid (PISF) biomarkers

  6 months

• Intraoral digital scan

  6 months

• Disease resolution

  6 months

• Severity of BoP

  6 months

• Probing pocket depth (PPD) reduction

  6 months

Study Arms (2)

Mechanical treatment arm + oral hygiene reinforcement

EXPERIMENTAL

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

Device: Ultrasonic debridement

Oral hygiene reinforcement alone

NO INTERVENTION

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

Interventions

Ultrasonic debridement DEVICE

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

Mechanical treatment arm + oral hygiene reinforcement

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

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

Oslo, 0455, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallell group two-arm randomised study

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 23, 2022
• Study Start: March 1, 2023
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)