Novel Photosensitizer in The Treatment of Chronic Periodontitis

May 5, 2020 updated by: Dr R Viswa Chandra, SVS Institute of Dental Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 509002
        • Recruiting
        • SVS Institute of Dental Sciences
        • Contact:
      • Hyderabad, Telangana, India, 509002
        • Recruiting
        • R V Chandra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: main treatment group
LASER assisted SRP followed by antimicrobial photodynamic therapy with a novel photosensitizer dye Phthalocyanine
Drug: Phthalocyanine Dye
following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
Other Names:
  • Experimental group
Drug: LASER assisted SRP
LASER assisted SRP will be carried
Other Names:
  • Control group
Placebo Comparator: control group
LASER assisted SRP
Drug: LASER assisted SRP
LASER assisted SRP will be carried
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 7-days.
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.
Change from baseline to 6-months.
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.
Change from baseline to 6-months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 6-months.
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.
Change from baseline to 6-months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SVS Institute of Dental Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVSIDS/PERIO/2/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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