Locally Delivered Atorvastatin & Rosuvastatin for Treatme... | NCT02800902

Studies
Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis

NCT02800902

Sponsor

Government Dental College and Research Institute, Bangalore

Status

Completed

Last Update Posted

Jun 15, 2016Estimated

Enrollment

90Actual

Phase

Phase 2Phase 3

Conditions

Chronic Periodontitis

Interventions

placebo
Rosuvastatin
Atorvastatin

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jun 7, 2016

First Submission Date that Met QC Criteria

Jun 14, 2016

First Posted Date

Jun 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2016

Last Update Posted Date

Jun 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. A R Pradeep, Professor and HOD, Dept of Periodontology, Government Dental College and Research Institute, BangalorePrincipal Investigator

Lead Sponsor

Government Dental College and Research Institute, BangaloreOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	Oral prophylaxis followed by placement of placebo gel	group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Bone defect fill	Assessed in percentage	baseline, 6 & 9 months

Secondary Outcomes

Measure	Description	Time Frame
Change in modified sulcus bleeding index	scale 0-3	baseline, 6 & 9 months
Change in Plaque index	scale 0-3	baseline, 6 & 9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Government Dental College and Research Institute		Bangalore	Karnataka	560002	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27715376	Derived	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.

ID	Term
D010518	Periodontitis
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
D000068718	Rosuvastatin Calcium
D000069059	Atorvastatin

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes