1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis

NCT03043196 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2014-2015HB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Defect depth reduction (%)

  assessed in percentage

  Change from baseline to 9 months

Secondary Outcomes (4)

• probing depth (mm)

  Change from baseline to 9 months

• clinical attachment level (mm)

  Change from baseline to 9 months

• modified sulcus bleeding index

  Change from baseline to 9 months

• Plaque Index

  Change from baseline to 9 months

Study Arms (2)

Rosuvastatin Group

ACTIVE COMPARATOR

Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects

Drug: SRP plus Rosuvastatin gel

Placebo Group

PLACEBO COMPARATOR

Oral prophylaxis followed by placebo gel placement in intrabony defects

Drug: SRP plus placebo gel

Interventions

SRP plus Rosuvastatin gel DRUG

SRP followed by Rosuvastatin placement into intrabony defect

Rosuvastatin Group

SRP plus placebo gel DRUG

SRP followed by placebo gel placement into intrabony defect

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Systemically healthy CP subjects aged between 30-50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an asymptomatic tooth were included in the study.
• A subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years

You may not qualify if:

• Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/ infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and HOD, Dept of Periodontology

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

IN (1)