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

Adult Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677297
• Other study ID #: DPU/R & R (D)/ 98(10)/ 16
• Status: Completed
• Phase: Phase 4
• Start date: January 28, 2016
• Est. completion date: November 10, 2017

Study information

• Verified date: September 2018
• Source: Dr. D. Y. Patil Dental College & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 10, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult Periodontitis
• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
India	Sukhada Deo	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Dr. D. Y. Patil Dental College & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing depth	Clinical parameters- Reduction in this parameter is desired at the end of 6 months	6 months
Secondary	relative attachment level	Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment	6 months
Secondary	plaque index	Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health	6 months
Secondary	bleeding index	Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health	6 months