ClinicalTrials.gg
Not yet recruitingNCT06523244Updated Jul 29, 2024

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

An interventional study of PHOTODYNAMIC THERAPY in Periodontal Pocket, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Not yet recruiting. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Periodontal Pocket

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03

In context

Periodontal Pocket

130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.

This study's planned enrollment of 24 is below the median of 30 across 113 interventional studies indexed under Periodontal Pocket.

Browse Periodontal Pocket studies →

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    test group

    PDT with chitosan nanoparticles enriched ICG

    Procedure: PHOTODYNAMIC THERAPY

  • Active comparator
    Control group

    PDT with ICG

    Procedure: PHOTODYNAMIC THERAPY

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.

06

What researchers measure

Primary outcomes

  1. MICROBIAL ANALYSIS

    LEVELS OF P. GINGIVALIS

    Time frame: 3 MONTHS

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Aug 2025, 13 months later.

Of 59 non-industry interventional studies with no phase under Periodontal Pocket, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 13 months is below that.

Counting every sponsor, half of 63 studies reached it within 16 months; a quarter within 9 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2024
First posted
Jul 26, 2024
StartEst.
Jul 2024
Primary completionEst.
Aug 2025
CompletionEst.
Aug 2025
Last update
Jul 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06523244
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Jul 26, 2024
Start date
Jul 2024 (estimated)
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Jul 29, 2024

Study contacts

DR.PRABHUJI MLV, MDS
Contact
prabhujimlv@gmail.com
9448057407 ext. 91
DR.MEGNA KM, MDS
Contact
kmmegna@gmail.com
8943811395 ext. 91

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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