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Completed

NCT Number: NCT05664425

Mechanical Treatment Peri-Implant Mucositis

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.

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Key information

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Oslo, 0455, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic debridement

Device

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

Primary outcomes

  1. Bleeding on probing (BoP) extent

    Time frame: 6 months

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

Secondary outcomes

  1. Peri-implant sulcus fluid (PISF) biomarkers

    Time frame: 6 months

    Biomarkers sampled at baseline, 3- and 6-months

  2. Intraoral digital scan

    Time frame: 6 months

    Volumetric change of soft tissue following peri-implant mucositis treatment

  3. Disease resolution

    Time frame: 6 months

    No BoP at any of the six probed sites at 6-month follow-up

  4. Severity of BoP

    Time frame: 6 months

    Reduction in the severity of BoP (graded from 0-3) at 6 months

  5. Probing pocket depth (PPD) reduction

    Time frame: 6 months

    Reduction in PPD at 6 months

  6. Bone level changes

    Time frame: 6 months

    Changes in bone level as assessed by radiographs at baseline and 6-months

  7. Onset of peri-implantitis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Acronym: MechTreatPiM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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