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Clinical Trial NCT07316023 for Stage III Periodontitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Antimicrobial Photodynamic Therapy With ICG-Loaded Nanoparticles for Periodontitis Management Phase 2 27
Clinical Trial NCT07316023 is designed to study Treatment for Stage III Periodontitis. It is a Phase 2 interventional study that is recruiting, having started on January 15, 2026, with plans to enroll 27 participants. Led by Nada Mahmoud Soliman, it is expected to complete by August 30, 2026. The latest data from ClinicalTrials.gov was last updated on January 5, 2026.
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 ...Show More
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 photodyn...
Show MoreOfficial Title
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 )
Conditions
Stage III PeriodontitisOther Study IDs
- Polymeric Nanoparticles /ICG
NCT ID Number
Start Date (Actual)
2026-01-15
Last Update Posted
2026-01-05
Completion Date (Estimated)
2026-08-30
Enrollment (Estimated)
27
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
periodontits/ stage III / NSPT/PDT/Nano particles/ ICG
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalNano 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). | 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 ComparatorMacro 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. | 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. |
OtherNegative 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. | Non- surgical periodontal therapy only supragingival scaling and subgingival debridement only |
Primary Outcome Measures
Secondary 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.
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 . |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
36 Years
Eligible Sexes
All
- 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:
- Smokers
- Pregnant females.
- Drug abusers.
- 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.
Nada Mahmoud SolimanStudy Responsible Party
Nada Mahmoud Soliman, Sponsor-Investigator, master Candidate at oral medicine and periodontology department faculty of dentistry ainshams university, Ain Shams University
Study Central Contact
Contact: Nada Soliman, BDS2017, 00201044219305, [email protected]
1 Study Locations in 1 Countries
Faculty of Dentistry , Ainshams University, Cairo, 11566, Egypt
Recruiting