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

NCT ID: NCT03677297

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-28
• Study Completion Date: 2017-11-10

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.

Conditions

Adult Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ROSUVASTATIN

1.2% Rosuvastatin Gel. Insertion in infrabony defects once

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel

placebo

No intervention used on control site

Group Type: PLACEBO_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel

Interventions

Rosuvastatin

Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel

Intervention Type: DRUG

Other Intervention Names

No intervention used on Control site

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. D. Y. Patil Dental College & Hospital

OTHER

Sponsor Role: lead

Responsible Party

DR. SUKHADA DEO

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sukhada D Deo, BDS

Role: PRINCIPAL_INVESTIGATOR

Dr. D. Y. Patil Dental College & Hospital

Locations

Sukhada Deo

Pune, Maharashtra, India

Countries

India

Other Identifiers

DPU/R & R (D)/ 98(10)/ 16

Identifier Type: -

Identifier Source: org_study_id