Photodynamic Therapy in Non-surgical Periodontal Therapy

NCT07080762 | Completed DMC

• 2 other identifiers: 4242CESCEthics Committee
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Photodynamic Therapy (PDT); Periodontitis; Antimicrobial Photodynamic Therapy

Keywords

Photodynamic Therapy; periodontitis

Outcome Measures

Primary Outcomes (2)

• Probing Pocket Depth PPD Index

  Probing depth is the distance from the gingival margin to the base of the pocket (mm)

  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.

  T0 (Baseline), T2 (14 days after baseline), T3 (3 months after baseline)

Secondary Outcomes (4)

• Recession REC Index

  T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)

• Clinical attachment level CAL Index

  T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)

• Plaque Index

  T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)

• Bleeding on probing BOP Index

  T0 (Baseline), T1(7 days after baseline), T2 (14 days after baseline), T3 (3 months after baseline)

Study Arms (2)

Experimental : antimicrobial photodynamic therapy (aPDT) after non-surgical therapy

EXPERIMENTAL

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

No intervention: non-surgical therapy

NO INTERVENTION

In the control group, non-surgical periodontal therapy was performed using both mechanical and manual instrumentation with curettes and ultrasonic devices.

Interventions

antimicrobial photodynamic therapy (aPDT) after non-surgical therapy DEVICE

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

Experimental : antimicrobial photodynamic therapy (aPDT) after non-surgical therapy

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 84 years;
• Good general health status;
• Diagnosis of severe periodontitis involving at least 30% of all teeth, with at least three non-adjacent teeth presenting three sites with probing pocket depth (PPD) greater than 4 mm in at least two quadrants, and having lost at least four teeth due to periodontitis;
• Presence of at least 16 teeth, with a minimum of four teeth per quadrant.

You may not qualify if:

• Pregnancy or breastfeeding;
• Presence of decompensated systemic diseases that may compromise the outcomes of the study or the patient's health;
• Regular use of antibiotics;
• Regular use of anti-inflammatory drugs (NSAIDs, corticosteroids, or aspirin);
• Use of anticoagulant medications;
• History of systemic antibiotic therapy within six months prior to enrollment;
• History of any periodontal therapy within six months prior to enrollment;
• Presence of severe mental or cognitive disorders.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Alessia Verona

Verona, VR, 37134, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 23, 2025
• Study Start: November 3, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-07

Locations

IT (1)