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

NCT03677297 | Completed Phase 4 DMC

• 1 other identifier: DPU/R & R (D)/ 98(10)/ 16
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Periodontitis

Keywords

Intervention Study; Rosuvastatin; Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Probing depth

  6 months

• relative attachment level

  6 months

• plaque index

  6 months

• bleeding index

  6 months

Study Arms (2)

ROSUVASTATIN

EXPERIMENTAL

1.2% Rosuvastatin Gel. Insertion in infrabony defects once

Drug: Rosuvastatin

placebo

PLACEBO COMPARATOR

No intervention used on control site

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

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

Also known as: No intervention used on Control site

ROSUVASTATIN; placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead

Study Sites (1)

Sukhada Deo

Pune, Maharashtra, 411018, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sukhada D Deo, BDS

  Dr. D. Y. Patil Dental College & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 19, 2018
• Study Start: January 28, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 10, 2017
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

IN (1)