Peri-Implantitis
Conditions
Keywords
Peri-implant disease, aMMP-8, Antibacterial photodynamic therapy (aBPT), Oral hygiene
Brief summary
The aim of this study is to determine the effect of regular antibacterial photodynamic Lumoral® treatment on gingival health and plaque volume, and anti-inflammatory effect of daily double light therapy on implant teeth. The study will use a medical device containing a light-activated Lumorinse® mouthwash and a Lumoral® light activator.
Detailed description
The hypothesis is that antibacterial photodynamic therapy improves tissue health by reducing inflammation without any side effect. Study participants will be invited from a dental clinic in Tampere, Finland, from the patients of an oral hygienist's office. Participants will be randomized to the treatment and control groups using the closed envelope method. Participants in the treatment group will receive Lumoral® treatment according to the manufacturer's protocol, once daily for 10 min for 15 days and then twice daily for 15 days.
Interventions
DEVICELumoral Treatment
Photodynamic antibacterial dual-light device with a marker substance
OTHERStandard treatment for peri-implantitis
Standard treatment for peri-implantitis as per international, national and clinic guidelines
Sponsors
University of Helsinki
Koite Health Oy
Hammasklinikka Kruunu
Hanna Lähteenmäki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants will be randomized at the end of baseline visit
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One or more dental implants * Diagnosis of peri-implantitis * Challenges in keeping high self-care oral care standards * Over 25 years of age
Exclusion criteria
\- Any antibiotic medication within 6 months prior to study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Active matrix metalloproteinase 8 (aMMP-8) | 30 days | Change in periodontal inflammation marker aMMP-8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing (BOP) | 30 days | Improvement in bleeding on probing (BOP) A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus Dichotomous scoring to each site of the tooth as bleeding 1 present and 0 absent BOP is reported as the percentage (%) of sites with positive findings Calculation formula: number of bleeding sites/ 6 times number of teeth |
| Visible plaque index (VPI) | 30 days | Change in visible plaque index |
Countries
Finland
Outcome results
None listed