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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Oslo, Norway
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
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