Stage III PeriodontitisPhase 2NCT07316023
Antimicrobial Photodynamic Therapy With ICG-Loaded Nanoparticles for Periodontitis Management
A Phase 2 study testing Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles, Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles and Non- surgical periodontal therapy only in people with Stage III Periodontitis, run by Nada Mahmoud Soliman at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 50 years
- Conditions the study is for
- Stage III Periodontitis
- What is being tested?
- Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles, Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles and Non- surgical periodontal therapy only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry , Ainshams University
Cairo, Cairo Governorate, 11566
About this study
Official 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 )
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."
Read the 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
- Being tested
- Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles, Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles, Non- surgical periodontal therapy only
- Keywords
- periodontits/ stage III / NSPT/PDT/Nano particles/ ICG
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticlesDrug
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.
Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticlesDrug
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.
Non- surgical periodontal therapy onlyOther
supragingival scaling and subgingival debridement only
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: Non- surgical periodontal therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- = plaque recognized only by running a probe across the marginal surface of implant restoration.
- = plaque visible to the naked eye.
- = abundance of soft matter.
Measured: 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
- = Mild inflammation - slight edema. No bleeding on probing
- = Moderate inflammation -redness, edema and glazing. Bleeding on probing.
- = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jun 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nada Mahmoud Soliman
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Nada Mahmoud Soliman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316023
- Sponsor's protocol ID
- Polymeric Nanoparticles /ICG
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 )
- ClinicalTrials.gov ID
- NCT07316023
- Acronym / sponsor ID
- Polymeric Nanoparticles /ICG
- Conditions
- Stage III Periodontitis
- Keywords
- periodontits/ stage III / NSPT/PDT/Nano particles/ ICG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nada Mahmoud SolimanUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nano Group | Experimental | Drug: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticlesThis 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). |
| Macro Group( positive control) | Active comparator | Drug: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticlesGroup (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. |
| Negative Control | Other | Other: Non- surgical periodontal therapy onlyGroup (III): Negative Control This group will include 9 patients diagnosed with stage III periodontitis and will be treated with non-surgical periodontal therapy only. |
Who may qualify
- Ages
- 36 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- To reduce any confounding factors and bias that may affect the results of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticlesSupragingival 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. | Drug | Nano Group |
| Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticlessupragingival scaling and subgingival debridement followed by ICG-loaded macroparticles activated by diode laser for antibacterial photodynamic therapy to effectively target and eliminate pathogenic bacteria. | Drug | Macro Group( positive control) |
| Non- surgical periodontal therapy onlysupragingival scaling and subgingival debridement only | Other | Negative Control |
Primary outcome
Plaque Index (unit:score)
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 .
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.
The Gingival index (unit=score )
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 .
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
Probing depth (PD) (Unit=mm)
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 .
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.
Clinical Attachment Loss (CAL) (Unit=mm)
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 .
- Clinical attachment level (CAL): (Ramfjord et al., 1975). Will be measured from the CEJ to the depth of the periodontal pocket.
1 secondary outcome
Microbial evaluation to detect bactericidal effect on Porhyromonas gingivalis.
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 respectively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles, Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles and Non- surgical periodontal therapy only in people with Stage III Periodontitis, run by Nada Mahmoud Soliman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (unit:score) (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 .). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.