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

NCT ID: NCT06523244

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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test group

PDT with chitosan nanoparticles enriched ICG

Group Type EXPERIMENTAL

PHOTODYNAMIC THERAPY

Intervention Type 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.

Control group

PDT with ICG

Group Type ACTIVE_COMPARATOR

PHOTODYNAMIC THERAPY

Intervention Type 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.

Interventions

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PHOTODYNAMIC 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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DR.PRABHUJI MLV, MDS

Role: CONTACT

9448057407 ext. 91

DR.MEGNA KM, MDS

Role: CONTACT

8943811395 ext. 91

Other Identifiers

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02_D012_00046

Identifier Type: -

Identifier Source: org_study_id

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