Periodontal PocketNCT06523244
Comparing Photodisinfection of Chitosan NP Enriched ICG Over ICG as Adjunct to OFD: RCT
A study testing PHOTODYNAMIC THERAPY in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- PHOTODYNAMIC THERAPY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Aug 2025
- Phase
- Interventional
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy subjects
- Age group 30-55yrs.
- Diagnosed with Stages II/III grade B/C periodontitis.
- Presenting with persistent pocket depth ≥5mm after initial non-surgical therapy.
- Optimal plaque control
- Good compliance
Who cannot join
- Subjects on antibiotic therapy within last six months of enrollment
- Previous history of periodontal surgery
- Allergy to drugs and materials used in this study
- Pregnant woman
- Subjects with deleterious habits like smoking, tobacco chewing.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Photo Disinfection With Chitosan Nanoparticles Enriched ICG Over ICG as an Adjunct to Open Flap Debridement in Stage II/III Grade B/C Periodontitis. RCT
The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis.
Read the detailed description
A total of 24 patients fulfilling inclusion criteria will be randomly assigned into two treatment groups (Test and Control). Open flap debridement followed by photodynamic therapy using dyes is carried out.
Test group (n=12) - PDT with Chitosan nanoparticles enriched ICG Control group(n=12) - PDT with ICG Microbial levels of P.gingivalis is analysed with PCR analysis on baseline and 3 months after intervention.
- Conditions
- Periodontal Pocket
- Being tested
- PHOTODYNAMIC THERAPY
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHOTODYNAMIC THERAPYProcedure or surgery
Respective photosensitive dye solution is applied on to the surgical site, including all the root surfaces. Vacuum suction is used to remove the excess dye from the site and to prevent ingestion of the dye solution The dye is activated with 810nm diode laser with continuous wave frequency and power of 0.3 W with 400 µm fiber tip for 20 seconds/spot. After this, the area is irrigated with saline.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | PDT with chitosan nanoparticles enriched ICG Receives: Procedure: PHOTODYNAMIC THERAPY |
| Control group | Active comparator | PDT with ICG Receives: Procedure: PHOTODYNAMIC THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
MICROBIAL ANALYSIS
LEVELS OF P. GINGIVALIS
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523244
- Sponsor's protocol ID
- 02_D012_00046
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Photo Disinfection With Chitosan Nanoparticles Enriched ICG Over ICG as an Adjunct to Open Flap Debridement in Stage II/III Grade B/C Periodontitis. RCT
- ClinicalTrials.gov ID
- NCT06523244
- Acronym / sponsor ID
- 02_D012_00046
- Conditions
- Periodontal Pocket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Jul 2024 (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.
The current study is a prospective randomised study-Comparison of photodisinfection with chitosan nanoparticles enriched indocyanine green over indocyanine green as an adjunct to open flap debridement in the management of stage II/III grade B/C periodontitis.
Detailed description
A total of 24 patients fulfilling inclusion criteria will be randomly assigned into two treatment groups (Test and Control). Open flap debridement followed by photodynamic therapy using dyes is carried out.
Test group (n=12) - PDT with Chitosan nanoparticles enriched ICG Control group(n=12) - PDT with ICG Microbial levels of P.gingivalis is analysed with PCR analysis on baseline and 3 months after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: PHOTODYNAMIC THERAPYPDT with chitosan nanoparticles enriched ICG |
| Control group | Active comparator | Procedure: PHOTODYNAMIC THERAPYPDT with ICG |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy subjects
- Age group 30-55yrs.
- Diagnosed with Stages II/III grade B/C periodontitis.
- Presenting with persistent pocket depth ≥5mm after initial non-surgical therapy.
- Optimal plaque control
Key exclusion criteria (5 listed)
- Subjects on antibiotic therapy within last six months of enrollment
- Previous history of periodontal surgery
- Allergy to drugs and materials used in this study
- Pregnant woman
- Subjects with deleterious habits like smoking, tobacco chewing.
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 |
|---|---|---|
| PHOTODYNAMIC THERAPYRespective photosensitive dye solution is applied on to the surgical site, including all the root surfaces. Vacuum suction is used to remove the excess dye from the site and to prevent ingestion of the dye solution The dye is activated with 810nm diode laser with continuous wave frequency and power of 0.3 W with 400 µm fiber tip for 20 seconds/spot. After this, the area is irrigated with saline. | Procedure or surgery | Control group, test group |
Primary outcome
MICROBIAL ANALYSIS
Time frame: 3 MONTHS
LEVELS OF P. GINGIVALIS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PHOTODYNAMIC THERAPY in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR.PRABHUJI MLV, MDS (9448057407 ext. 91, prabhujimlv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MICROBIAL ANALYSIS (time frame: 3 MONTHS). 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 29 Jul 2024.