Peri-implantitis and its prevention.
Tord Berglundh, Søren Jepsen, Bernd Stadlinger...
https://pubmed.ncbi.nlm.nih.gov/30636066/Actively Recruiting
Led by Koite Health Oy · Updated on 2025-08-05
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
Researchers are investigating a new at-home photodynamic and antibacterial blue light therapy combined with non-surgical professional treatment to manage peri-implant mucositis, an inflammation of the tissue around dental implants without bone loss. This condition affects a large portion of dental implants and can lead to implant failure if untreated. The study will measure improvements in plaque, bleeding, pocket depth, and inflammation markers in the gum fluid to assess treatment effects. Participants will be randomly assigned to one of two groups one receiving standard oral hygiene care including professional cleaning, oral hygiene instructions, and antiseptic gel, and the other group using a home-based dual-light photodynamic therapy device alongside regular oral hygiene. The device uses a mouthguard-shaped LED light to activate a photosensitizer in a mouth rinse, producing antibacterial effects. Treatments and evaluations will take place over 6 and 12 months. During the study, participants will undergo clinical assessments such as bleeding on probing, plaque scoring, pocket depth measurements, and biomolecular analysis of gum fluid. Changes in the width of keratinized gum tissue and patient-reported outcomes will also be monitored. Follow-up visits will reinforce oral hygiene and track safety and effectiveness over the study period, which lasts up to 12 months.
CONDITIONS
Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
M
Mikko Kylmänen, Master of Health Care
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Koite Health Oy
Lead Sponsor
University of Roma La Sapienza
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive standard oral hygiene care and may also use a home-based antibacterial medical device involving photodynamic therapy to treat peri-implant mucositis.
Regular follow-up visits for assessment during treatment
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
University of Roma La Sapienza
Collaborating Sponsor