PDT As An Adjunct To SRP In The Management of Chronic Periodontitis
- Conditions
- Chronic Periodontitis
- Registration Number
- NCT03770819
- Lead Sponsor
- KLE Society's Institute of Dental Sciences
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Microbial profile 3 months Change in levels of P.gingivalis following PDT
- Secondary Outcome Measures
Name Time Method Change in Gingival index score 3 months Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
Change in Plaque index score 3 months Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
Probing pocket depth 3 months Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
Clinical attachment level 3 months Gain in clinical attachment level following PDT