Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03770819
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2018-12-06
Brief Title:
PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
Sponsor:
KLE Societys Institute of Dental Sciences
Organization:
KLE Societys Institute of Dental Sciences
Study Overview
Official Title:
Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
NOT_YET_RECRUITING
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:
The present study aims to evaluate photodynamic therapy PDT using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing SRP in the management of chronic periodontitis
Detailed Description:
Following full mouth SRP each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities
Group 1 control - Application of placebo gel followed by sham PDT Directing the Light cure device without turning on the light beam
Group 2 -Application of Zinc oxide gel followed by sham PDT Group 3 - Application of placebo gel followed by PDT Group 4 - Application of Zinc oxide gel followed by PDT The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline end of 1 week and 1 month from the first session
Clinical parameters and microbial profile will be recorded at baseline before commencement of Periodontal treatment end of 1 month and end of 3 months following periodontal treatment
Zinc oxide gelplacebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom it completely fills the periodontal pockets The gel will be retained in the pocket for 5 minutes The perio tip will be attached to the hand piece of the light cure unit Wavelength 420-480nm Light power 1200mwcm2 in continuous mode and light will be activated for 60 seconds Following this the pockets will be irrigated with normal saline solution 09Sodium chloride
Group 1 control - Application of placebo gel followed by sham PDT Directing the Light cure device without turning on the light beam
Group 2 -Application of Zinc oxide gel followed by sham PDT Group 3 - Application of placebo gel followed by PDT Group 4 - Application of Zinc oxide gel followed by PDT The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline end of 1 week and 1 month from the first session
Clinical parameters and microbial profile will be recorded at baseline before commencement of Periodontal treatment end of 1 month and end of 3 months following periodontal treatment
Zinc oxide gelplacebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom it completely fills the periodontal pockets The gel will be retained in the pocket for 5 minutes The perio tip will be attached to the hand piece of the light cure unit Wavelength 420-480nm Light power 1200mwcm2 in continuous mode and light will be activated for 60 seconds Following this the pockets will be irrigated with normal saline solution 09Sodium chloride
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?:
None
Is an FDA AA801 Violation?:
None