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NCT Number: NCT06523244

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

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Key information

Conditions

Periodontal Pocket Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photodynamic Therapy

Procedure

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.

Primary outcomes

  1. MICROBIAL ANALYSIS

    Time frame: 3 MONTHS

    LEVELS OF P. GINGIVALIS

Study contacts

Contact information is provided by the study sponsor or research team.

DR.MEGNA KM, MDS

CONTACT

[email protected]

8943811395 ext. 91

DR.PRABHUJI MLV, MDS

CONTACT

[email protected]

9448057407 ext. 91

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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