Single Session Of Antimicrobial Photodynamic Therapy Using Indocyanine Green

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-12-31

Brief Summary

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In recent years, there has been a growing interest in the use of dental lasers for treatment of periodontal diseases. Commercially available photodynamic therapy for periodontal diseases utilizes methylene blue as a photosensitizer. In this study, the effects of a novel photosensitizer dye, indocyanine green (ICG), as an adjunct to nonsurgical treatment of chronic periodontitis will be evaluated.

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Detailed Description

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Background and objective: Periodontal disease is caused by periodontal pathogens that colonize the dental plaque and the subsequent host-microbial interactions. The recent years have witnessed a rapid increase in the usage of Light Amplification by Stimulated Emission of Radiation (Laser) in dentistry for the treatment of periodontal diseases. The additive therapeutic effects when a photoactivated dye such as methylene blue is used in conjunction with Laser is well documented. Indocyanine green (ICG), a tri-carbocyanine that belongs to family of cyanine dyes is widely used in the fields of Ophthalmology and Cardiac imaging. Recent in vitro studies have reported its efficacy in killing potent periodontal pathogens like A. actinomycetemcomitans and P. gingivalis when combined with 810 nm diode laser. The present study aims at evaluating the effects of ICG as an adjunct to non-surgical treatment of chronic periodontitis in biofilm environment of human periodontal pockets in terms of immediate reduction in percentage of viable bacteria and at the same to quantitatively assess host tissue injury. Methods: The study included 30 patients diagnosed with chronic periodontitis. Three sites from three different quadrants were selected and assigned to three groups namely, SRP group - scaling and root planing, LASER group - scaling and root planing with application of 810 nm diode laser and ICG group - scaling and root planing with application of 810 nm diode laser and ICG at a concentration of 5 mg/mL. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Indocyanine green (ICG)

The study included 30 patients diagnosed with chronic periodontitis. Three sites from three different quadrants were selected and assigned to three groups namely, SRP group - scaling and root planing, LASER group - scaling and root planing with application of 810 nm diode laser and ICG group - scaling and root planing with application of 810 nm diode laser and ICG at a concentration of 5 mg/mL. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Group Type EXPERIMENTAL

indocyanine green

Intervention Type DRUG

ICG group - scaling and root planing with application of 810 nm diode laser and ICG at a concentration of 5 mg/mL. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

LASER

Intervention Type DEVICE

LASER group - scaling and root planing with application of 810 nm diode laser Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Scaling and Root Planing

Intervention Type PROCEDURE

SRP group - scaling and root planning. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Interventions

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indocyanine green

ICG group - scaling and root planing with application of 810 nm diode laser and ICG at a concentration of 5 mg/mL. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Intervention Type DRUG

LASER

LASER group - scaling and root planing with application of 810 nm diode laser Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Intervention Type DEVICE

Scaling and Root Planing

SRP group - scaling and root planning. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.

Intervention Type PROCEDURE

Other Intervention Names

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Cardiogreen Photosensitizer Diode LASER Non-surgical Periodontal Therapy

Eligibility Criteria

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Inclusion Criteria

Patients who were diagnosed with chronic periodontitis having a clinical evidence of periodontal pocket of ≥5mm, in at least 4 sites in each of the 3 quadrants.

* Systemically healthy male \& female patients within the age group of 35-55 years.
* No history of medications affecting the periodontium (antibiotics, immunosuppressive drugs, anti-inflammatory, anti-oxidants, antibiotic tooth paste, mouthwashes) or periodontal therapy in the past 24 weeks period leading to the study.

Materials \& Methods 26

\- Minimum of 5 teeth in each quadrant.

Exclusion Criteria

Medically compromised patients.

* Patients who had received any antibiotic, periodontal or laser therapy during the past 24 weeks of base line examination.
* Patients using antibacterial mouth rinses or medicated tooth paste during the past 24 weeks.
* Patients with history of tobacco chewing, smoking and alcohol consumption.
* Pregnant women \& lactating mothers.

Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes