SPiT-frequency II_Peri-implantitis
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 Non-surgical protocol on implants diagnosed with peri-implantitis.
The study is a part of a project assessing the frequency of supportive peri-implant therapy. The current is on non-surgical treatment of peri-implantitis (inflammation and exposed implant surface). The other study is a RCT on treatment of peri-implant mucositis (inflammation and no attachment loss at the implants) and secondary prevention of peri-implant mucositis (REK 790097). 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
This trial does not accept healthy volunteersQualifiers
- Subject must be ≥ 20 years, diagnosed with peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018) with a bone level > 3 mm from the expected initial bone level Peri-implantitis: Bleeding after gentle probing at an implant and radiographic bone level > 3 mm
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
Design model
Parallel
Treatments tested in this trial
Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning
Procedure/SurgeryThe treatment under study is professional non-surgical, submucosal debridement with ultrasonic instruments with PolyEther Ether Ketone (PEEK)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Test. Increased treatment frequencyExperimental treatment 1 intervention
Group B: Control. Conventional frequencyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peri-implant inflammation
To assess the proportion of implants without signs of inflammation (eradication of disease). Inflammation is defined as Bleeding on Probing (BoP) and/or suppuration
Time frame
From baseline to 9 monthsSecondary outcomes
1
Improvement of inflammation severity
Bleeding index (BI) 3, 2, 1, 0 (Roos-Jansåker et al., 2007)
Time frame
From baseline to 9 monthsOther outcomes
1
Extent of inflammation
Number of inflamed sites at the implants (0-6)
Time frame
Baseline to 9 months2
Reduction of pocket probing depths
Pocket depths in mm
Time frame
Baseline to 9 months3
Buccal keratinized mucosa
Height of keratinized mucosa at the buccal aspect of the implant (in mm)
Time frame
Baseline to 9 months4
Progressive bone loss
Radiographic changes in bone level at the implant (in mm)
Time frame
Baseline to 9 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: