An interventional study of Ultrasonic debridement in Peri-implant Mucositis, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 20 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by University of Oslo · Not applicable, Interventional, and Treatment
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.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 56 is above the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip.
Device: Ultrasonic debridement
Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation.
Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)
Bleeding on probing (BoP) extent
Reduction in the extent of BoP as measured on six sites per implant
Time frame: 6 months
Peri-implant sulcus fluid (PISF) biomarkers
Biomarkers sampled at baseline, 3- and 6-months
Time frame: 6 months
Intraoral digital scan
Volumetric change of soft tissue following peri-implant mucositis treatment
Time frame: 6 months
Disease resolution
No BoP at any of the six probed sites at 6-month follow-up
Time frame: 6 months
Severity of BoP
Reduction in the severity of BoP (graded from 0-3) at 6 months
Time frame: 6 months
Probing pocket depth (PPD) reduction
Reduction in PPD at 6 months
Time frame: 6 months
Bone level changes
Changes in bone level as assessed by radiographs at baseline and 6-months
Time frame: 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.
Time frame: 6 months
Plan to share: No — IPD will be available for other researchers upon reasonable request and as long as in accordance with ethical committee and national GDPR rules.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Oslo