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
1 other identifier
interventional
24
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJuly 29, 2024
July 1, 2024
1.1 years
July 19, 2024
July 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
MICROBIAL ANALYSIS
LEVELS OF P. GINGIVALIS
3 MONTHS
Study Arms (2)
test group
EXPERIMENTALPDT with chitosan nanoparticles enriched ICG
Control group
ACTIVE COMPARATORPDT with ICG
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2024
First Posted
July 26, 2024
Study Start
July 1, 2024
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
July 29, 2024
Record last verified: 2024-07