SPiT-frequency I_Peri-implant Mucositis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorUniversity of Oslo

About this trial

This is an interventional clinical study on the peri-implant treatment necessary to improve the clinical conditions surrounding dental implants registered with peri-implant inflammation. The focus of this double-armed, examiner blinded, controlled, randomized clinical trial is to examine the effect of short-term increased frequency of a SPiT (supportive peri-implant treatment) protocol on implants diagnosed with peri-implant mucositis.

The study is a part of a project assessing the frequency of supportive peri-implant therapy. The current is on treatment of peri-implant mucositis (inflammation and no attachment loss at the implants) and secondary prevention of peri-implant mucositis. The other study is a RCT on non-surgical treatment of peri-implantitis (inflammation and exposed implant surface) (REK 790240). Exposure of rough surface may dramatically change the frequency of maintenance needed to improve the inflammatory condition. Thus, a segregation between adequate and low bone level at the implant is necessary.

Subjects with more than one implant and both diagnoses, may be enrolled in both studies, following the frequency of treatment randomized in the peri-implant mucositis study.

Eligibility criteria

Qualifiers

Subject must be ≥ 20 years, diagnosed with peri-implant mucositis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018) at an adequate (<0.5mm) bone level Peri-implant mucositis: Bleeding after gentle probing at an implant and no radiographic bone loss)

Disqualifiers

Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.

No pregnant or nursing subjects.

> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification.

HIV positive or other disease severely affecting the immune system

Trial design

Treatments tested in this trial

  • Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators