Novel Photosensitizer in The Treatment of Chronic Periodontitis

Overview

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.

Full Title of Study: “Clinical Effects of a Single Application of a Novel Photosensitizer in The Treatment of Chronic Periodontitis – A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 2020

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: main treatment group
    • LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
  • Placebo Comparator: control group
    • LASER assisted SRP

Clinical Trial Outcome Measures

Primary Measures

  • Release profile of the drug
    • Time Frame: 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)
    • Time Frame: 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.
  • clinical attachment level (CAL)
    • Time Frame: 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • SVS Institute of Dental Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr R Viswa Chandra, Primary Investigator – SVS Institute of Dental Sciences
  • Overall Contact(s)
    • RVchandra, MDS; DNB, 9908183071, viswachandra@hotmail.com

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