Novel Photosensitizer in The Treatment of Chronic Periodontitis

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

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

Conditions
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Periodontitis, Alveolar Bone Loss

Intervention / Treatment
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* Drug: Phthalocyanine Dye
* Drug: LASER assisted SRP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: main treatment group<br>LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine | Drug: Phthalocyanine Dye<br>* following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed<br>* Other names: Experimental group;Drug: LASER assisted SRP<br>* LASER assisted SRP will be carried<br>* Other names: Control group;|
| Placebo Comparator: control group<br>LASER assisted SRP | Drug: LASER assisted SRP<br>* LASER assisted SRP will be carried<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |