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

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

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

Study Overview

• Status: Completed
• Conditions: Adult Periodontitis
• Intervention / Treatment: Drug: Rosuvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411018
      • Sukhada Deo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Dr. D. Y. Patil Dental College & Hospital
• Investigators: Principal Investigator: Sukhada D Deo, BDS, Dr. D. Y. Patil Dental College & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): November 10, 2017

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Periodontitis; Intervention Study; Rosuvastatin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: DPU/R & R (D)/ 98(10)/ 16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No