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Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.
Source from where the patients will be selected:
10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.
A detailed clinical examination, case history and written consent will be obtained from all the participants.
Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROSUVASTATIN | Experimental | 1.2% Rosuvastatin Gel. Insertion in infrabony defects once |
|
| placebo | Placebo Comparator | No intervention used on control site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone fill | Radiographic parameter measuring distance from cemento-enamel junction to the base of the defect. Difference in the measurement at the end of 6 months shows the amount of bone fill | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth | Clinical parameters- Reduction in this parameter is desired at the end of 6 months | 6 months |
| relative attachment level | Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sukhada D Deo, BDS | Dr. D. Y. Patil Dental College & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sukhada Deo | Pune | Maharashtra | 411018 | India |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| 6 months |
| plaque index | Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health | 6 months |
| bleeding index | Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health | 6 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |