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

Dr. D. Y. Patil Dental College & Hospital

Status and phase

Completed

Phase 4

Conditions

Adult Periodontitis

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03677297

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

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.