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PeriodontitisPhase 2NCT02043340

Single Session Of Antimicrobial Photodynamic Therapy Using Indocyanine Green

A Phase 2 study testing indocyanine green, LASER and Scaling and Root Planing in people with Periodontitis, run by SVS Institute of Dental Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Periodontitis
What is being tested?
indocyanine green, LASER and Scaling and Root Planing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Oct 2012to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Effect of A Single Session Of Antimicrobial Photodynamic Therapy Using Indocyanine Green In The Treatment Of Chronic Periodontitis

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.

Read the detailed description

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
Periodontitis
Being tested
indocyanine green, LASER, Scaling and Root Planing
Keywords
Periodontitis, Bacterial viability, Lactate dehydrogenase levels, Indocyanine green, Scaling and root planing, Antimicrobial photodynamic therapy.
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • indocyanine greenDrug

    Also called Cardiogreen, Photosensitizer

    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.

  • LASERDevice

    Also called Diode 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.

  • Scaling and Root PlaningProcedure or surgery

    Also called Non-surgical Periodontal Therapy

    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.

Study groups in NCT02043340
Study groupRoleWhat they receive
Indocyanine green (ICG)ExperimentalThe 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.
Receives: Drug: indocyanine green; Device: LASER; Procedure: Scaling and Root Planing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to 1 week

Secondary outcomes (1)

  1. LDH

    LDH activity is used as an indicator of relative cell viability and plasma membrane integrity.,28 Quantitative total LDH was assayed by using a commercially available kit (LDH-Cytotoxicity Assay Kit II (Colorimetric) ®, Abcam, Cambridge, MA, USA). Initially, 10 μL of mammalian cell lysis solution (Cell Lysis Solution, Abcam, Cambridge, MA, USA) was added to every 100 μL of the GCF collected which was subsequently incubated at 30ºC for 5 minutes. The manufacturer's instructions were subsequently followed and the absorbance at 450nm background after subtracting the zero well/NADH background from all readings was recorded by using a colorimetric microplate reader (iMark™ Microplate Absorbance Reader, Bio-Rad, Hyderabad, India). The results are expressed as total LDH activity (mUnits/site) per sample where one unit LDH is the amount of enzyme that catalyzes the conversion of lactate to pyruvate to generate 1.0 μmol to NADH per minute at 37°C.

    Measured: Baseline to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02043340
Sponsor's protocol ID
SVS031102
Other IDs
SVS031102
Status last verified
Jan 2014
First submitted
18 Jan 2014
Last updated
23 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing indocyanine green, LASER and Scaling and Root Planing in people with Periodontitis, run by SVS Institute of Dental Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacterial Vitality (time frame: Baseline to 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02043340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.

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