Novel Photosensitizer in The Treatment of Chronic Periodontitis

Periodontitis Clinical Trial

Official title:

Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374383
• Other study ID #: SVSIDS/PERIO/2/2019
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: November 2021

Study information

• Verified date: May 2020
• Source: SVS Institute of Dental Sciences
• Contact: RVchandra, MDS; DNB
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the periodontal outcomes after applying antimicrobial photodynamic therapy with a novel photosensitizer as compared to LASER assisted scaling and root planing alone.

Description:

LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine will be done in test group subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Systemically healthy male and female patients of age 30-60 years with generalized probing pocket depths (PPD) indicative of chronic periodontitis and with atleast two sites with PPD =5mm in each quadrant

Exclusion Criteria:

• Medically compromised patients, Subjects with a history of periodontal intervention within 6 months of the commencement of the study and smokers

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Phthalocyanine Dye
following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
• LASER assisted SRP
LASER assisted SRP will be carried

Locations

Country	Name	City	State
India	R V Chandra	Hyderabad	Telangana
India	SVS Institute of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Release profile of the drug	Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.	Change from baseline to 7-days.
Primary	probing pocket depths (PPD)	Assessment of probing pocket depths (PPD, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.	Change from baseline to 6-months.
Primary	clinical attachment level (CAL)	Assessment of clinical attachment level (CAL, in mm) by using a manual periodontal probe on six sites (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual and distolingual) will be performed.	Change from baseline to 6-months.
Secondary	plaque index (PI)	Assessment of plaque (PI) - according to Turesky modification of Quigley and Hein Plaque Index; 0-No plaque 1-Isolated flecks of plaque at the gingival margin 2-A continuous band of plaque up to 1mm at the gingival margin 3-Plaque greater than 1mm in width and covering up to one third of the tooth surface 4-Plaque covering from one thirds to two thirds of the tooth surface 5-Plaque covering more than two thirds of the tooth surface.	Change from baseline to 6-months.
Secondary	bleeding on probing (BOP)	Assessment of bleeding on probing (BOP) as a dichotomous variable ("Yes"/"No") by using a manual periodontal probe.	Change from baseline to 6-months.