Antimicrobial Photodynamic Therapy With ICG-Loaded Nanoparticles for Periodontitis Management

NCT07316023 | Recruiting Phase 2 DMC

• 1 other identifier: Polymeric Nanoparticles /ICG
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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."

Conditions

Stage III Periodontitis

Keywords

periodontits/ stage III / NSPT/PDT/Nano particles/ ICG

Outcome Measures

Primary Outcomes (4)

• 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. 1. = plaque recognized only by running a probe across the marginal surface of implant restoration. 2. = plaque visible to the naked eye. 3. = 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 1. = Mild inflammation - slight edema. No bleeding on probing 2. = Moderate inflammation -redness, edema and glazing. Bleeding on probing. 3. = 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 Outcomes (1)

• Microbial evaluation to detect bactericidal effect on Porhyromonas gingivalis.

  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

Study Arms (3)

Nano Group

EXPERIMENTAL

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

Macro Group( positive control)

ACTIVE COMPARATOR

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

Negative Control

OTHER

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

Interventions

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

Nano Group

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

Macro Group( positive control)

Non- surgical periodontal therapy only OTHER

supragingival scaling and subgingival debridement only

Negative Control

Eligibility Criteria

• Age: 36 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Smokers
• Pregnant females.
• Drug abusers.
• Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.
• To reduce any confounding factors and bias that may affect the results of this study.

Sponsors & Collaborators

• Nada Mahmoud Soliman: lead

Study Sites (1)

Faculty of Dentistry , Ainshams University

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Nada Soliman, BDS2017

CONTACT

00201044219305; nadamahmoudsoliman@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: master Candidate at oral medicine and periodontology department faculty of dentistry ainshams university

Model Details: Patients will be randomly allocated using computer-generated randomization (www.Randomizer.org ) into three groups of nine each. Group I will receive non-surgical periodontal therapy (NSPT) combined with ICG-loaded polymeric nanoparticles and antimicrobial photodynamic therapy (aPDT). Group II (positive control) will receive NSPT with ICG gel and aPDT, while Group III (negative control) will receive NSPT alone. After full-mouth debridement and baseline GCF and clinical data collection, the photosensitizer will be applied for 10 minutes, followed by diode laser irradiation (940 nm, 0.5 W, continuous mode, 30 seconds per site using a 0.3 nm E3 tip in contact mode). Excess gel will be removed after activation, and aPDT will be performed once. All patients will receive oral hygiene instructions, and clinical and GCF evaluations will be conducted at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: January 5, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)