Diode Laser Photo Activation for Pocket Reduction Decontamination A Clinical Study

NCT06404190 | Completed Phase 1

• 1 other identifier: KCDSHEC/IP/2023/P11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Routine non surgical periodontal thearpy often fails to achieve complete elimination of pathogenic microorganism. This could be attiributable to deep periodontal pockets, root concavities, furcation involvement etc. Systemic and local antimicrobials have been used adjunctively with scaling and root planning to optimize the results. They have their own draw backs namely antibiotic resistance and narrow spectrum of action over periodontal pathogens. In the last decade lasers applications have diversified occupying greater part of the periodontal treatment strategies. Photodynamic thearpy has shown conflicting results as a adjunctive thearpy. The routinely used dyes are Methyelene blue, indocyanine green and rose bengal .These dyes are difficult to procure and may not be economical . Hydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost effective. It could be used for photodisinfection . From the near-infrared spectrum lasers, the Nd-YAG laser can remove periodontal pathogens because of its thermal effect. However, changes in the neighboring tissues can be attributed to these unwanted thermal effects. The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative.Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on calculus. Anaerobic bacterial species intermedia produce black pigments in Brucella media from blood agar. Hemoglobin in the soft periodontal tissues behaves like a chromophore, being absorbed by the diode laser. Photoactivated procedure use photolysis of hydrogen peroxide with 810nm laser. It acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS stopped immediately after the laser irridation. Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjuvantive to SRP to optimize clinical outcome.

Conditions

Pocket, Periodontal; Periodontal Inflammation; Periodontal Attachment Loss; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Probing pocket Depth

  1\. Probing pocket Depth (PPD), dept measuring from cej to depth of pocket through william probe

  3 months

Secondary Outcomes (1)

• DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY

  3 month

Study Arms (1)

DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY

EXPERIMENTAL

1)To evaluate the effectiveness of 3% hydrogen peroxide as an adjunct to scaling and root planning with diode laser irriadation 2. To compare the clinical and microbiology outcome of SRP + 3% hydrogen peroxide + diode laser and SRP alone

Combination Product: Diode laser and 3% hydrogen peroxide

Interventions

Diode laser and 3% hydrogen peroxide COMBINATION_PRODUCT

Hydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost-effective. It could be used for photo disinfection along with lasers. The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative. Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on hard tissues and deposits. The photoactivation procedure uses photolysis of hydrogen peroxide with 810nm laser. Hydrogen peroxide acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS. Thus the combination of 3% H2O2 and laser light generate hydroxyl radicals as a result of photoactivation. Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjunctive to SRP to optimize clinical outcomes.

DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients ≥18 years of age Minimum of 5mm of periodontal probing depth Patient under going orthodontic prosthodontic restorative treatment Stage 2 and 3 Grade B and C periodontitis acc to 2017 classification
• Exclusive Criteria:
• Pregnacy systemic disease people

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Anusha s

Bengaluru, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Periodontal Pocket; Periodontal Attachment Loss; Periodontitis

Interventions

Lasers, Semiconductor; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: GROUP A: 10 SRP ALONE GROUP B: 10 SRP+3%HYDROGEN PEROXIDE+DIODE LASER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: GROUP A: ultrasonic GROUP B: laser and hydrogen peroxide

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 8, 2024
• Study Start: May 28, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 15, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

IN (1)