Antimicrobial Photodynamic Therapy With ICG-Loaded Nanoparticles for Periodontitis Management
ConditionStage III Periodontitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age36-50
SponsorNada Mahmoud Soliman
About this trial
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."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Smokers
Pregnant females.
Drug abusers.
Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles
DrugSupragingival 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.
Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles
Drugsupragingival scaling and subgingival debridement followed by ICG-loaded macroparticles activated by diode laser for antibacterial photodynamic therapy to effectively target and eliminate pathogenic bacteria.
Non- surgical periodontal therapy only
Other interventionsupragingival scaling and subgingival debridement only
Treatment groups
27 Participants
are divided into 3 treatment groupsGroup A: Nano GroupExperimental treatment 1 intervention
Group B: Macro Group( positive control)Active comparator 1 intervention
Group C: Negative ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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 .2
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
Time frame
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 .3
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.
Time frame
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 .4
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.
Time frame
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.
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.
Time frame
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 respectivelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Nada Mahmoud Soliman
Lead sponsor
Ain Shams University
Sponsor institution
Source ClinicalTrials.gov