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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Photodynamic therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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
Interventional Model Description: 16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. 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. Study period - 3 months
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Application of placebo gel followed by sham Photodynamic therapy | Procedure: Photodynamic therapy<br>* 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.<br>|
| Active Comparator: Zinc oxide gel group<br>Application of Zinc oxide gel followed by sham Photodynamic therapy. | Procedure: Photodynamic therapy<br>* 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.<br>|
| Experimental: PDT group<br>Application of placebo gel followed by Photodynamic therapy. | Procedure: Photodynamic therapy<br>* 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.<br>|
| Experimental: Zinc oxide and PDT group<br>Application of Zinc oxide gel followed by Photodynamic therapy. | Procedure: Photodynamic therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Microbial profile | Change in levels of P.gingivalis following PDT | 3 months | 

Secondary Outcome Measures

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