Antimicrobial Photodynamic Therapy With ICG-Loaded Nanoparticles for Periodontitis Management

NCT ID: NCT07316023

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-08-30

Brief Summary

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."

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

Conditions

Stage III Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles

Intervention Type: DRUG

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.

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.

Group Type: OTHER

Non- surgical periodontal therapy only

Intervention Type: OTHER

supragingival scaling and subgingival debridement only

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Non- surgical periodontal therapy only

supragingival scaling and subgingival debridement only

Intervention Type: OTHER

Eligibility Criteria

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

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.

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nada Mahmoud Soliman

OTHER

Sponsor Role: lead

Responsible Party

Nada Mahmoud Soliman

master Candidate at oral medicine and periodontology department faculty of dentistry ainshams university

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry , Ainshams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nada Soliman, BDS2017

Role: CONTACT

nadamahmoudsoliman@dent.asu.edu.eg

00201044219305

Other Identifiers

Polymeric Nanoparticles /ICG

Identifier Type: -

Identifier Source: org_study_id