PDT As An Adjunct To SRP In The Management of Chronic Periodontitis

Overview

The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.

Full Title of Study: “Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis – A Split Mouth Double Blind Randomized Controlled Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: May 2019

Detailed Description

Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities. Group 1 (control) – Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam). Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 – Application of placebo gel followed by PDT. Group 4 – Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session. Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment. Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).

Interventions

  • Procedure: Photodynamic therapy
    • Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride). For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo group
    • Application of placebo gel followed by sham Photodynamic therapy
  • Active Comparator: Zinc oxide gel group
    • Application of Zinc oxide gel followed by sham Photodynamic therapy.
  • Experimental: PDT group
    • Application of placebo gel followed by Photodynamic therapy.
  • Experimental: Zinc oxide and PDT group
    • Application of Zinc oxide gel followed by Photodynamic therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Microbial profile
    • Time Frame: 3 months
    • Change in levels of P.gingivalis following PDT

Secondary Measures

  • Change in Plaque index score
    • Time Frame: 3 months
    • Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
  • Change in Gingival index score
    • Time Frame: 3 months
    • Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
  • Probing pocket depth
    • Time Frame: 3 months
    • Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
  • Clinical attachment level
    • Time Frame: 3 months
    • Gain in clinical attachment level following PDT

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health. – Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants. Exclusion Criteria:

  • Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study. – Subjects on antibiotics or immunosuppressant medication 6 months prior to the study. – Chronic Smokers, Alcoholics, Smokeless tobacco users. – Subjects with acute illnesses/acute intraoral lesions. – Pregnant women and lactating mothers. – Medically compromised subjects.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • KLE Society’s Institute of Dental Sciences
  • Collaborator
    • University of Mysore
  • Provider of Information About this Clinical Study
    • Principal Investigator: Veena H.R, Reader, Department of Periodontics – KLE Society’s Institute of Dental Sciences

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