Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects

Study Overview
=================
Brief Summary
-----------------
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.

Detailed Description
-----------------
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.

Official Title
-----------------
Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study

Conditions
-----------------
Adult Periodontitis

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group between 30-50 years Probing pocket depth ≥ 5mm following initial therapy. Suitable interproximal angular infrabony defects of ≥3mm. Involved teeth should be vital and asymptomatic. Systemically healthy patients. Patients who demonstrate acceptable oral hygiene prior to access flap surgery. Patients agreed to sign informed consent and willing to return for the follow up visits. Exclusion Criteria: Systemic statin therapy Known or suspected allergy to the statin group Allergy to sulfur containing drugs History of aggressive periodontitis. Presence of gingival recession at the surgical site. Mobility of study teeth ≥ grade I. Use of tobacco in any form. Pregnant and lactating women. patients who have received any anti-inflammatory drugs and antibiotics in the previous six months. H/O osteoporosis.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROSUVASTATIN<br>1.2% Rosuvastatin Gel. Insertion in infrabony defects once | Drug: Rosuvastatin<br>* Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel<br>* Other names: No intervention used on Control site;|
| Placebo Comparator: placebo<br>No intervention used on control site | Drug: Rosuvastatin<br>* Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel<br>* Other names: No intervention used on Control site;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intervention Study, Rosuvastatin, Periodontitis