Novel Photosensitizer in The Treatment of Chronic Periodontitis

Phase 2

• Conditions: Periodontitis; Alveolar Bone Loss
• Interventions: Drug: Phthalocyanine Dye; Drug: LASER assisted SRP

• Registration Number: NCT04374383
• Lead Sponsor: SVS Institute of Dental Sciences

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-30
• Status Verified: 2020-05
• Study First Posted: 2020-05-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-07
• Primary Completion: 2020-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
main treatment group	Phthalocyanine Dye	LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
control group	LASER assisted SRP	LASER assisted SRP
main treatment group	LASER assisted SRP	LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine

Primary Outcome Measures

Name	Time	Method
clinical attachment level (CAL)	Change from baseline to 6-months.	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.
Release profile of the drug	Change from baseline to 7-days.	Release profile of the drug in Gingival Crevicular Fluid (GCF) samples will be evaluated through biochemical testing kits.
probing pocket depths (PPD)	Change from baseline to 6-months.	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.

Secondary Outcome Measures

Name	Time	Method
plaque index (PI)	Change from baseline to 6-months.	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.
bleeding on probing (BOP)	Change from baseline to 6-months.	Assessment of bleeding on probing (BOP) as a dichotomous variable ("Yes"/"No") by using a manual periodontal probe.

Trial Locations

Locations (2)

R V Chandra; 🇮🇳 Hyderabad, Telangana, India

SVS Institute of Dental Sciences; 🇮🇳 Hyderabad, Telangana, India