Killing of harmful germs in the mouth with the help of Coloring agent and visible light

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/03/008239
• Date of registration: 28-03-2017
• Prospective Registration: No
• Primary sponsor: SDM College of Dental Sciences and Hospital
• Public title: Killing of harmful germs in the mouth with the help of Coloring agent and visible light
• Scientific title: Effect of erythrosine mediated Photodynamic Antimicrobial Chemotherapy(PACT) on Plaque Microorganisms
• Date of first enrolment: 21-06-2012
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12814
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr KVV Prasad
• Affiliation: SDM College of Dental Sciences and Hospital

• Name: Dr Manohara A Bhat Y
• Affiliation: SDM College of Dental Sciences and Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects with minimum of 20 sound natural teeth,

2. Male and Female subjects, who had similar plaque scores on the contralateral tooth of the same arch.

3. Available for entire duration of the study.


Exclusion criteria: 1. Presence of orthodontic appliance or more than one incisor with prosthetic crown.

2. Required immediate care.

3. Destructive periodontal disease.

4. Pregnant and breast feeding women.

5. Chronic systemic conditions (heart, kidneys, liver, or infectious diseases including AIDS).

6. Undergoing antibiotic or steroid therapy in the preceding month.

7. History of allergies to dental products or their ingredients.

8. Oral prophylaxis in the preceding month or periodontal treatment in the preceding 3 months.

8. Gross dental caries

9. Fixed and removable partial dentures

10. History or current use of recreational drug



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Erythrosine and Dental Curing Light: A dental curing light is a piece of dental equipment that is commonly used in dental clinic for polymerization of light cure resin based composites.
Dose: 10 ml of 25µM Erythrosine solution(Topical Rinse); Light Dose: 39.82 J/cm2(Topical) Frequency: Only once, Rout of Administration: Topical route Duration: 60 seconds
Intervention2: Erythrosine and Dental Curing Light: A dental curing light is a piece of dental equipment that is commonly used in dental clinic for polymerization of light cure resin based composites.
Dose: 10 ml of 25µM Erythrosine solution(Topical Rinse); Light Dose: 39.82 J/cm2(Topical)
Frequency: Only once,
Rout of Administration: Topical route
Duration: 60 seconds
Control Intervention1: Erythrosine: Erythrosine, also known as Red No. 3, is an organoiodine compound; commonly used in Plaque disclosing agents and food coloring agent.

Primary Outcome(s)

Reduction in Dental plaque microorganism is observed in the experimental group.Logarithmic mean and standard deviation of control group with 102 dilutions of aerobic microbial count were found to be 5.34± 0.94 and for experimental group, it was 4.47± 1.37. Similarly logarithmic mean and standard deviation of control and experimental group with 102 dilutions of anaerobic microbial count were found to be 6.18 ± 0.66 and 5.64±1.008 respectively.Timepoint: 60 sec.

Secondary Outcome(s)

Reduction of dental plaque microorganismsTimepoint: 30 sec or more

Secondary ID(s)

NIL

Source(s) of Monetary Support

Dept. of Microbiology; SDM College of Medical Sciences

Dept. of Public Health Dentistry; SDM College of Dental Sciences

Ethics review

Status: Approved
Approval date: 26/11/2011
Contact:

SDM College of Dental Sciences