NCT02800902

Brief Summary

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

June 7, 2016

Last Update Submit

June 14, 2016

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Bone defect fill

    Assessed in percentage

    baseline, 6 & 9 months

Secondary Outcomes (5)

  • Change in modified sulcus bleeding index

    baseline, 6 & 9 months

  • Change in Plaque index

    baseline, 6 & 9 months

  • Change in pocket probing depth

    baseline, 6 & 9 months

  • Change in relative vertical clinical attachment level

    baseline, 6 & 9 months

  • Change in relative horizontal clinical attachment level

    baseline, 6 & 9 months

Study Arms (3)

group 1

PLACEBO COMPARATOR

Scaling and root planing (SRP) followed by placebo gel local drug delivery

Drug: placebo

group 2

ACTIVE COMPARATOR

SRP followed by 1.2% rosuvastatin (RSV) gel

Drug: Rosuvastatin

group 3

ACTIVE COMPARATOR

SRP followed by 1.2% Atorvastatin (ATV) gel

Drug: Atorvastatin

Interventions

placeboDRUG

Oral prophylaxis followed by placement of placebo gel

Also known as: inactive drug
group 1
RosuvastatinDRUG

Oral prophylaxis followed by placement of rosuvastatin gel

Also known as: RSV
group 2
AtorvastatinDRUG

Oral prophylaxis followed by placement of atorvastatin gel

Also known as: ATV
group 3

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study

You may not qualify if:

  • Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

Related Publications (1)

  • Garg S, Pradeep AR. 1.2% Rosuvastatin and 1.2% Atorvastatin Gel Local Drug Delivery and Redelivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):259-265. doi: 10.1902/jop.2016.160399. Epub 2016 Oct 7.

    PMID: 27715376DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

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

June 7, 2016

First Posted

June 15, 2016

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations

IN(1)