An interventional study of antimicrobial photodynamic therapy (aPDT) after non-surgical therapy in Photodynamic Therapy (PDT), Periodontitis and Antimicrobial Photodynamic Therapy, sponsored by Universita di Verona. Completed at 1 site in Italy. Open to participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Universita di Verona · Not applicable, Interventional, and Treatment
Non-surgical periodontal therapy is a widely adopted procedure for the treatment of periodontitis, particularly in its moderate to severe stages. The approach involves the mechanical and manual debridement of subgingival biofilm and calculus through the use of ultrasonic scalers and hand curettes. This method aims to disrupt the pathogenic bacterial load within periodontal pockets and promote clinical attachment gain while reducing inflammation. However, the mechanical removal of biofilm alone may not always ensure complete bacterial eradication, especially in deep or anatomically complex sites.
To enhance bacterial disinfection and optimize clinical outcomes, adjunctive use of antimicrobial photodynamic therapy (aPDT) has been introduced. aPDT is a non-invasive technique that involves the activation of a photosensitizing agent by light at a specific wavelength, leading to the production of reactive oxygen species capable of selectively damaging microbial cells. This reaction occurs without affecting surrounding healthy tissues and has been shown to be effective against a broad spectrum of periodontal pathogens.
The synergistic effect of combining conventional non-surgical periodontal therapy with aPDT allows for a more comprehensive decontamination of periodontal pockets. In particular, aPDT contributes to the disruption of residual bacterial biofilm that may persist after mechanical instrumentation, thereby potentially improving both short- and long-term periodontal stability. In addition to its antimicrobial action, aPDT may exert a biostimulatory effect, enhancing tissue healing through increased local microcirculation and cellular activity.
This study aims to evaluate the clinical efficacy of adjunctive antimicrobial photodynamic therapy following non-surgical periodontal treatment in patients with severe periodontitis. The protocol involves initial subgingival instrumentation using ultrasonic and manual tools, followed by the application of a photosensitizer and subsequent laser activation within the periodontal pockets. The hypothesis of this study is that the addition of aPDT provides superior bacterial reduction and improved clinical outcomes compared to mechanical therapy alone.
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This study's enrollment of 50 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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The test group received antimicrobial photodynamic therapy (aPDT) immediately after non-surgical treatment. A diode laser with a wavelength of 660 nm was used (Helbo® TheraLite Laser, Bredent, Germany). The photosensitizer (Helbo® Biofilm Marker), based on phenothiazine chloride and supplied in pre-packaged sterile syringes, was delivered into the periodontal pocket using a sterile syringe with a flat tip. The photosensitizer was left in situ for 60 seconds. Subsequently, all periodontal pocket walls were irradiated for ten seconds each (disto-lingual, lingual, mesio-lingual, mesio-buccal, buccal, disto-buccal), for a total duration of 60 seconds.
Device: antimicrobial photodynamic therapy (aPDT) after non-surgical therapy
In the control group, non-surgical periodontal therapy was performed using both mechanical and manual instrumentation with curettes and ultrasonic devices.
In the test, a photoactive substance activated with laser light (20 mW, 660 nm) was applied to the post-non-surgical site for 60 seconds to promote disinfection Other Name: antimicrobial photodynamic therapy (aPDT) after non surgical therapy
Probing Pocket Depth PPD Index
Probing depth is the distance from the gingival margin to the base of the pocket (mm)
Time frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)
Microbiological analysis
The microbiological analysis qualitatively (yes/no) assesses the presence of six types of periodontopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Treponema denticola, Actinomyces naeslundii) using sterile paper points inserted into the periodontal pocket prior to non-surgical periodontal therapy. For each site analyzed, two saliva samples are collected: one is placed in a test tube containing ethanol, and the other in a tube containing ammonium thioglycolate. The samples are subsequently transported to the microbiology department of the Integrated University Hospital of Verona for analysis.
Time frame: T0 (Baseline), T2 (14 days after baseline), T3 (3 months after baseline)
Recession REC Index
Recession is the apical shift of the marginal tissues associated with the attachment loss exposing the root or implant surface to the oral environment (mm)
Time frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)
Clinical attachment level CAL Index
measured in mm as distance from the CEJ to the gingival margin (GM)
Time frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)
Plaque Index
This index ascertains the thickness of plaque along the gingival margin (%)
Time frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)
Bleeding on probing BOP Index
is an indicator of tissue inflammatory response to bacterial pathogens (%)
Time frame: T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Universita di Verona