Peri-implant Mucositis
Conditions
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.
Interventions
DEVICEUltrasonic debridement
Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)
Sponsors
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Investigator-blinded
Intervention model description
Parallell group two-arm randomised study
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BoP) extent | 6 months | Reduction in the extent of BoP as measured on six sites per implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoral digital scan | 6 months | Volumetric change of soft tissue following peri-implant mucositis treatment |
| Disease resolution | 6 months | No BoP at any of the six probed sites at 6-month follow-up |
| Severity of BoP | 6 months | Reduction in the severity of BoP (graded from 0-3) at 6 months |
| Peri-implant sulcus fluid (PISF) biomarkers | 6 months | Biomarkers sampled at baseline, 3- and 6-months |
| Bone level changes | 6 months | Changes in bone level as assessed by radiographs at baseline and 6-months |
| Onset of peri-implantitis | 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. |
| Probing pocket depth (PPD) reduction | 6 months | Reduction in PPD at 6 months |
Countries
Norway
Outcome results
None listed