Single Session Of Antimicrobial Photodynamic Therapy Using Indocyanine Green

NCT02043340 | Completed Phase 2 DMC

• 1 other identifier: SVS031102
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontitis

Keywords

Periodontitis; Bacterial viability; Lactate dehydrogenase levels; Indocyanine green; Scaling and root planing; Antimicrobial photodynamic therapy.

Outcome Measures

Primary Outcomes (1)

• Bacterial Vitality

  Percentage of viable bacteria were estimated from the subgingival plaque samples at baseline, immediately after treatment and at the end of 1 week using a commercially available bacterial viability kit (LIVE/DEAD® BacLight™ Bacterial Viability Kit, Invitrogen, Leiden, The Netherlands).

  Baseline to 1 week

Secondary Outcomes (1)

• LDH

  Baseline to 1 week

Other Outcomes (1)

• Measures of Periodontal Health

  Baseline to Six months

Study Arms (1)

Indocyanine green (ICG)

EXPERIMENTAL

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.

Drug: indocyanine green; Device: LASER; Procedure: Scaling and Root Planing

Interventions

indocyanine green 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.

Also known as: Cardiogreen, Photosensitizer

Indocyanine green (ICG)

LASER 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.

Also known as: Diode LASER

Indocyanine green (ICG)

Scaling and Root Planing 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.

Also known as: Non-surgical Periodontal Therapy

Indocyanine green (ICG)

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Indocyanine Green; Photosensitizing Agents; Lasers; Lasers, Semiconductor; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Radiation-Sensitizing Agents; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Sripriya Nagarajan, MDS

  SVS Institute of Dental Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: January 18, 2014
• First Posted: January 23, 2014
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 23, 2014

Record last verified: 2014-01