ICG-loaded nanoparticle photodynamic therapy for stage III periodontitis

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 )

This test tries to see if packing a light-activated dye (ICG) into tiny biodegradable nanoparticles and activating it with a gentle laser after deep cleaning reduces harmful gum bacteria and improves gum health in people with stage III periodontitis better than dye alone or cleaning alone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 36 Years to 50 Years
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07316023 on ClinicalTrials.gov

What this trial studies

This randomized, controlled Phase 2 trial enrolled 27 patients with generalized stage III grade B periodontitis and randomly assigned them to three groups: non-surgical periodontal therapy (NSPT) alone, NSPT plus ICG gel with antimicrobial photodynamic therapy (aPDT), or NSPT plus ICG-loaded polymeric nanoparticles with aPDT. After full-mouth supra- and subgingival debridement, photosensitizer was applied for 10 minutes where indicated and activated with a 940 nm diode laser (0.5 W, continuous, 30 seconds per site, six sites per tooth). Clinical outcomes (plaque index, gingival index, probing depth, clinical attachment level) and microbiological samples from gingival crevicular fluid were collected at baseline, immediately after treatment (selected times), and at 1 week, 3 months, and 6 months. The protocol standardized oral hygiene instructions for all participants and excluded smokers, pregnant women, recent antibiotic users, and those with systemic conditions that might affect periodontal healing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 36–50 with generalized stage III grade B periodontitis (posterior sites with PD > 6 mm and CAL ≥ 5 mm) who can follow oral hygiene instructions, are non-smokers, not pregnant, not on recent antibiotics, and have no systemic diseases affecting treatment.

Not a fit: Patients who smoke, are pregnant, use drugs, have systemic conditions that affect periodontal healing, recently took antibiotics or had periodontal treatment, or who need surgical therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a stronger, non-surgical way to reduce periodontal bacteria and improve gum attachment without using additional antibiotics.

How similar studies have performed: Antimicrobial photodynamic therapy with ICG or other photosensitizers has shown promise in prior small studies for reducing periodontal bacteria, but delivering ICG in biodegradable nanoparticles is a more recent approach with limited human data.

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:

* 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.

Where this trial is running

Cairo

• Faculty of Dentistry , Ainshams University — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Nada Soliman, BDS2017

Conditions: Stage III Periodontitis, periodontits/ stage III / NSPT/PDT/Nano particles/ ICG