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Comparing Photodisinfection of Chitosan NP Enriched ICG Over ICG as Adjunct to OFD: RCT

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523244
Enrollment
24
Registered
2024-07-26
Start date
2024-07-31
Completion date
2025-08-31
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Pocket

Brief 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.

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.

Interventions

PROCEDUREPHOTODYNAMIC THERAPY

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.

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
MICROBIAL ANALYSIS3 MONTHSLEVELS OF P. GINGIVALIS

Contacts

Primary ContactDR.PRABHUJI MLV, MDS
prabhujimlv@gmail.com9448057407
Backup ContactDR.MEGNA KM, MDS
kmmegna@gmail.com8943811395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026