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| Name | Class |
|---|---|
| University of Mysore | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Application of placebo gel followed by sham Photodynamic therapy |
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| Zinc oxide gel group | Active Comparator | Application of Zinc oxide gel followed by sham Photodynamic therapy. |
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| PDT group | Experimental | Application of placebo gel followed by Photodynamic therapy. |
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| Zinc oxide and PDT group | Experimental | Application of Zinc oxide gel followed by Photodynamic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Microbial profile | Change in levels of P.gingivalis following PDT | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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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
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This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
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| 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 |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |