Antimicrobial Photodynamic Therapy With ICG-Loaded Nanoparticles for Periodontitis Management

Efficacy of Antimicrobial Photodynamic Therapy Using Polymeric Nanoparticles Loaded With Indocyanine Green in Management of Periodontitis.(A Randomized Controlled Clinical Trial Study With Microbiological Analysis )

To better understand and treat your gum disease, dentists now use a system that stages its severity and grades its speed, rather than using old labels. The recommended first step is almost always a deep cleaning, which is very effective. However, because some bacteria can hide from cleanings and antibiotics, researchers are exploring a promising light-based treatment. This method uses a safe, light-activated dye and a gentle laser to target and kill bacteria without leading to resistance. To make this treatment even stronger, scientists are testing a way to package the dye inside tiny, biodegradable "containers" that deliver it directly to the germs. The goal of this research is to see if this advanced delivery method works better than the dye alone, hoping to provide a more powerful, non-surgical option to fight gum disease and protect your teeth."

Study Overview

• Status: Recruiting
• Conditions: Stage III Periodontitis
• Intervention / Treatment: Drug: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles; Drug: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles; Other: Non- surgical periodontal therapy only

Detailed Description

This randomized controlled clinical trial included twenty-seven patients diagnosed with generalized stage III periodontitis, who were randomly allocated into three groups using a computer-generated randomization sequence (www.randomizer.org

). Group I (test group) received non-surgical periodontal therapy followed by the application of indocyanine green (ICG)-loaded polymeric nanoparticles and antimicrobial photodynamic therapy (aPDT). Group II (positive control) received non-surgical periodontal therapy with ICG gel application alone and aPDT, whereas Group III (negative control) received non-surgical periodontal therapy only. Following full-mouth supra- and subgingival debridement, baseline clinical measurements and gingival crevicular fluid (GCF) samples were obtained. In Groups I and II, after achieving site dryness, the photosensitizer was applied for 10 minutes, rinsed, and activated using a 940 nm diode laser (0.5 W, continuous mode, non-initiated E3 tip, contact mode, 30 seconds per site, six sites per tooth). Standardized oral hygiene instructions were provided to all participants. Clinical and microbiological evaluations were performed at baseline, 3 months, and 6 months post-treatment. Clinical parameters including plaque index, gingival index, probing depth, and clinical attachment level were recorded using a UNC-15 probe. For microbiological analysis, GCF samples from the most affected sites were collected at baseline, immediately post-treatment, 1 week, and 1 month, and analyzed by polymerase chain reaction (PCR) to quantify Porphyromonas gingivalis. Samples contaminated with blood or saliva were excluded, and uncontaminated samples were transported in reduced transport fluid (RTF) and cultured under anaerobic conditions for bacterial quantification.

The obtained results will be collected, tabulated, and subjected to appropriate statistical analysis

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nada Soliman, BDS2017; Phone Number: 00201044219305; Email: nadamahmoudsoliman@dent.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Recruiting
    • Faculty of Dentistry , Ainshams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1- Both genders aged between 36-50 years (Wadhwa et al., 2021) 2- Generalized stage III grade B periodontitis (Papapanou et al., 2018). Posterior teeth, stage III with PD>6 mm and CAL ≥5 mm 3- Patients ready to comply with oral hygiene measures. 4- Patients free from any systemic disease that may affect the treatment (Glick et al., 2008)

Exclusion Criteria:

• Exclusion criteria:

  1. Smokers
  2. Pregnant females.
  3. Drug abusers.
  4. Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.

Justification for Exclusions:

To reduce any confounding factors and bias that may affect the results of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano Group; This group will include 9 patients diagnosed with generalized stage III periodontitis and will be treated with non-surgical periodontal treatment + ICG-loaded polymeric nanoparticles + antimicrobial photodynamic therapy (aPDT).	Drug: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles; Supragingival scaling and subgingival debridement followed by placement of ICG-loaded nanoparticles activated by diode laser for antibacterial photodynamic therapy to effectively target and eliminate pathogenic bacteria.
Active Comparator: Macro Group( positive control); Group (II): Positive Control This group will include 9 patients diagnosed with generalized stage III periodontitis and will be treated with non-surgical periodontal treatment + ICG gel application alone + antimicrobial photodynamic therapy.	Drug: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles; supragingival scaling and subgingival debridement followed by ICG-loaded macroparticles activated by diode laser for antibacterial photodynamic therapy to effectively target and eliminate pathogenic bacteria.
Other: Negative Control; Group (III): Negative Control This group will include 9 patients diagnosed with stage III periodontitis and will be treated with non-surgical periodontal therapy only.	Other: Non- surgical periodontal therapy only; supragingival scaling and subgingival debridement only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (unit:score)	Clinical parameters including plaque index, gingival index, probing pocket depth (PPD), and clinical attachment level (CAL) will be recorded at baseline, 3, and 6 months using a UNC-15 probe by a calibrated examiner. The plaque and gingival indices (Löe and Silness, 1963) assess oral hygiene and inflammation. The following clinical parameters will be taken using the UNC15 Probe at baseline, 3 months, and 6 months postoperative. - Plaque index: - (Loe and Silness, 1963) 0 = no plaque.; = plaque recognized only by running a probe across the marginal surface of implant restoration.; = plaque visible to the naked eye.; = abundance of soft matter.	from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
The Gingival index (unit=score )	The following clinical parameters will be taken using UNC15 Probe at baseline, 3 months and 6 months postoperative. - Gingival index: -(Loe and Silness ,1963) 0 = Normal gingiva; = Mild inflammation - slight edema. No bleeding on probing; = Moderate inflammation -redness, edema and glazing. Bleeding on probing.; = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding	from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
Probing depth (PD) (Unit=mm)	Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe The average of the three facial points will be recorded as the facial probing depth (FPD), while the mid-lingual point will be recorded as the lingual probing depth.	from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
Clinical Attachment Loss (CAL) (Unit=mm)	- Clinical attachment level (CAL): (Ramfjord et al., 1975). Will be measured from the CEJ to the depth of the periodontal pocket.	from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial evaluation to detect bactericidal effect on Porhyromonas gingivalis.	Microbiological analysis will assess P. gingivalis levels in gingival crevicular fluid (GCF) using PCR at baseline, immediately post-treatment, one week, and one month. GCF samples will be collected from the most affected site using sterile paper strips, avoiding blood or saliva contamination, and stored in reduced transport fluid. Samples will be cultured and analyzed by PCR for P. gingivalis quantification. Results will compare microbial reduction among groups to evaluate the antimicrobial efficacy of nano- and macro-formulated photosensitizer gels versus conventional debridement.	from enrollment to the end of treatment at 6 months GCF samples will be collected from the deepest, most affected sites at baseline line , immediate postlaser treatment and after one month respectively

Collaborators and Investigators

• Sponsor: Nada Mahmoud Soliman

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: periodontits/ stage III / NSPT/PDT/Nano particles/ ICG
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: Polymeric Nanoparticles /ICG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No