Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Periodontitis Wth Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

change in defect depth
assessed in percentage
6 and 9 months

Secondary Outcomes (4)

change in probing depth (PD)
baseline, 6 and 9 months
change in Clinical Attachment Level (CAL)
baseline, 6 and 9 months
CHANGE IN Plaque Index (PI)
baseline, 6 and 9 months
change in modified Sulcus Bleding Index (mSBI)
baseline, 6 and 9 months

Study Arms (3)

GROUP 1

ACTIVE COMPARATOR

Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery

Drug: ATORVASTATIN

GROUP 2

ACTIVE COMPARATOR

Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery

Drug: SIMVASTATIN

GROUP 3

PLACEBO COMPARATOR

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

Drug: PLACEBO

Interventions

ATORVASTATINDrug

Scaling and Root Planing (SRP) followed by placement of atorvastatin gel

Also known as: ATV

GROUP 1

SIMVASTATINDrug

Scaling and Root Planing (SRP) followed by placement of simvastatin gel

Also known as: SMV

Eligibility Criteria

Age35 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[IOPAR\] after phase I therapy

You may not qualify if:

Sponsors & Collaborators

Government Dental College and Research Institute, Bangalore
Otherlead

Study Sites (1)

Department of Periodontics, GDCRI Bangalore

Bangalore, Karnataka, 560002, India

MeSH Terms

Interventions

AtorvastatinSimvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

Avani R Pradeep, MDS
GDCRI, Bangalore, INDIA
PRINCIPAL INVESTIGATOR

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
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, Department of periodontology

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 19, 2018

Study Start

March 3, 2017

Actual (reported)

Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

GROUP 1

GROUP 2

GROUP 3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

GROUP 1

GROUP 2

GROUP 3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations