Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404190
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-04-10
Brief Title:
Diode Laser Photo Activation for Pocket Reduction Decontamination A Clinical Study
Sponsor:
Krishnadevaraya College of Dental Sciences Hospital
Organization:
Krishnadevaraya College of Dental Sciences Hospital
Study Overview
Official Title:
DIODE LASER PHOTOACTIVATION OF 3 HYDROGEN PEROXIDE FOR POCKET DECONTAMINATION A CLINICAL STUDY
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 alternativeBecause 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 3hydrogen peroxide has been utilized adjuvantive to SRP to optimize clinical outcome
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 SRPH2O2photoactivation 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 11 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 for30 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 tubesindividual 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
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 tubesindividual 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None