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

KLE Society's Institute of Dental Sciences16 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

Photodynamic therapyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Microbial profile

Change in levels of P.gingivalis following PDT

Time frame: 3 months

Secondary Outcomes

Change in Plaque index score

Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT

Time frame: 3 months

Change in Gingival index score

Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT

Time frame: 3 months

Probing pocket depth

Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT

Time frame: 3 months

Clinical attachment level

Gain in clinical attachment level following PDT

Time frame: 3 months

Data from ClinicalTrials.gov

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