Diode Laser Photo Activation for Pocket Reduction Decontamination A Clinical Study

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Attachment Loss; Periodontal Inflammation; Pocket, Periodontal
• Intervention / Treatment: Combination product: Diode laser and 3% hydrogen peroxide

Detailed Description

This study was designed as a randomized controlled single-blind clinical trial to assest the antimicrobial effect of non surgical periodontal thearpy with SRP alone , and photoactivation of 3% H2O2 with 810nm diode in combination with SRP. Based on the method of randomization, each patient was allocated to one of the two treatment groups as follows: Group 1: SRP as monotherapy; Group 2: SRP+H2O2photoactivation with diode laser. One week after the baseline periodontal examination and microbiological sampling, scaling and root planning is carried out using conventional ultrasonic scaler .Every patient received oral hygiene instructions that included modified BASS brushing technique . In Group 1- Only SRP: Group 2- 3% H2O2solution was inserted to the bottom of the periodontal pocket using a disposable plastic needle similar to the endodontic irrigation followed by diode 810 nm laser irridation with 1.1 W, continuous wave (CW) with 300mm The activated fiber was applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements were performed for*30 sec per test surface. Microbiological assessment was performed 1 week before periodontal treatment.

Microbiological samples were obtained from the selected periodontal pockets at baseline (before treatment) and at 1 month after the periodontal treatment by the examiner. Sterile paper points will be placed into periodontal pocket to collect the gcf sample for 30 sec, then it is transfer to Eppendorf tubes(individual sampling) having (thioglycate broth) and incubated for 2 hrs then broth is( vortex). Later sample is cultured on the anerobic blood agar media and incubated in gas jar with anerobic gas pack for 48hrs and colony counting is done after 48hrs of incubation. Clinical periodontal parameters PPD, BOP, CAL and mobility were assessed baseine and 3 months after the periodontal treatment.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 562157
      • Anusha s

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket Depth	1. Probing pocket Depth (PPD), dept measuring from cej to depth of pocket through william probe	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY	Colony count	3 month

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontal Atrophy; Periodontitis; Inflammation; Periodontal Pocket; Periodontal Attachment Loss; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: KCDSHEC/IP/2023/P11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No