Peri-implantitis and its prevention.
Tord Berglundh, Søren Jepsen, Bernd Stadlinger...
https://pubmed.ncbi.nlm.nih.gov/30636066Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06017817
Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
Led by Nilminie Rathnayake · Updated on 2024-10-18
80
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
N
Nilminie Rathnayake
Lead Sponsor
U
University of Helsinki
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Lumoral method in managing peri-implantitis, a condition characterized by inflammation around dental implants. This early-stage study aims to determine how well this antibacterial photodynamic therapy can help control plaque above the gum line, which may support long-term control below the gum line. The device might also have a beneficial effect on the tissues supporting the implant, potentially aiding implant integration. The study compares different treatment approaches including Lumoral Treatment combined with standard non-surgical care such as scaling and root planing (SRP) and oral hygiene instructions, as well as surgical anti-infective treatments with or without Lumoral. Participants use the Lumoral device, which involves swishing a photoactive mouth rinse that binds to dental plaque and then activating it with a light applicator at home. All groups receive guidance on electric toothbrushing, interdental brush, and floss use. Participants will be monitored over six months with assessments including bleeding on probing, measurement of inflammatory markers like active matrix metalloproteinase 8 (aMMP-8), periodontal pocket depth, plaque indexes, bacterial flora, and questionnaires about oral health impact. Safety is evaluated by tracking adverse events. The trial involves regular dental visits to perform these evaluations and assess treatment effects and tissue health over time.
CONDITIONS
Brief Title
Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Have a periodontal pocket depth of 6 mm or more and marginal bone loss greater than 3 mm
- Have dental implants clinically characterized according to Lähteenmäki et al. CEDR-22
- Agree to participate and sign a written consent form
- Be able to follow the treatment protocol and avoid other oral hygiene measures outside the study
You will not qualify if you...
- Have any physical limitation that could prevent use of the Lumoral device
- Are unwilling to participate in the study
- Are pregnant or lactating
- Are active smokers
- Have medicated diabetes mellitus
- Have systemic diseases affecting peri-implantitis progression
- Have used antibiotics, doxycycline, chlorhexidine, or bisphosphonates within 4 weeks prior
- Have had peri-implant or periodontal treatment within 3 months prior
- Have removable major prosthesis or major orthodontic appliances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants receive either non-surgical or surgical anti-infective treatment for peri-implantitis, combined with standard oral hygiene instructions. Some participants will use the Lumoral photodynamic therapy device at home as part of their treatment.
Multiple visits depending on treatment group and protocol
Follow-up
Duration - Up to 6 months
Participants are monitored for treatment effects and potential adverse events for up to 6 months after treatment initiation.
Regular visits for assessments during the 6-month period
Trial Site Locations
Total: 1 location
1
Södertandläkarna AB
Stockholm, Sweden, 11622
Actively Recruiting
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Research Team
M
Mikko Kylmänen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Primary prevention of peri-implantitis: managing peri-implant mucositis.
Søren Jepsen, Tord Berglundh, Robert Genco...
https://pubmed.ncbi.nlm.nih.gov/25626479Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression.
N J Kassebaum, E Bernabé, M Dahiya...
https://pubmed.ncbi.nlm.nih.gov/25261053Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors.
N J Kassebaum, A G C Smith, E Bernabé...
https://pubmed.ncbi.nlm.nih.gov/28792274Risk factor assessment tools for the prevention of periodontitis progression a systematic review.
Niklaus P Lang, Jean E Suvan, Maurizio S Tonetti
https://pubmed.ncbi.nlm.nih.gov/25496279Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study.
Hanna Lähteenmäki, Tommi Pätilä, Ismo T Räisänen...
https://pubmed.ncbi.nlm.nih.gov/35723308Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque.
Sakari Nikinmaa, Niina Moilanen, Timo Sorsa...
https://pubmed.ncbi.nlm.nih.gov/34063662Derivation and validation of a short-form oral health impact profile.
G D Slade
https://pubmed.ncbi.nlm.nih.gov/9332805