Anti-infective effect of non-surgical treatment with and without photodynamic therapy on peri-implantitis: a pilot multicenter prospective randomized controlled clinical trial
- Conditions
- Mukositis/Periimplantitis
- Registration Number
- DRKS00011454
- Lead Sponsor
- Klinik für Mund-, Kiefer- und Gesichtschirurgie im UKSH, Campus Kiel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 3
ages=18.
- Subjects with at least one implant with peri-implantitis. The peri-implantitis is defined as: PPD of 4-6mm combined with BOP+, and bone loss of 2-4mm on peri-apical radiographs (taken by paralleling technique with splints for reproducible X-rays) compared to the time point of restoration placement.
- Availability for the 12 month duration of the study
- Signed Informed Consent Form.
- Subject with severe systemic diseases. (e.g. uncontrolled hypertension, uncontrolled diabetes, severe coagulation disorder, acute hepatitis, acute nephritis and myocardial infarction history less than 6 months).
- Pregnant or lactating females
- Patients have history of periodontitis
- Patients have history of receiving bisphosphonate therapy
- Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review
- Subjects treated for >2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the prescreening examination
- Allergy to dye phenothiazine chlorid (Toloniumchlorid or Toluidinblue) or mouth rinse with chlorhexidine
- Unwilling to participate in the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At baseline and after 12months:<br>MBL: marginal bone loss - clinical record<br>
- Secondary Outcome Measures
Name Time Method At baseline and each 3months-visit during 12months:<br>BOP%: percentage of bleeding on probing - clinical record<br>PPD: pocket probing depth in mm - clinical record<br>Peri-implant bacteria profile - clincal record