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.

Chronic Periodontitis Wth Diabetes Mellitus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745300
• Other study ID #: GDCRI/ACM/PG/Ph.D/5/2016-2017H
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 3, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: November 2018
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).

Description:

Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis Wth Diabetes Mellitus
• Diabetes Mellitus
• Periodontitis

Intervention

Drug:
• ATORVASTATIN
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
• SIMVASTATIN
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
• PLACEBO
Scaling and Root Planing (SRP) followed by placement of placebo gel

Locations

Country	Name	City	State
India	Department of Periodontics, GDCRI Bangalore	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in defect depth	assessed in percentage	6 and 9 months
Secondary	change in probing depth (PD)		baseline, 6 and 9 months
Secondary	change in Clinical Attachment Level (CAL)		baseline, 6 and 9 months
Secondary	CHANGE IN Plaque Index (PI)		baseline, 6 and 9 months
Secondary	change in modified Sulcus Bleding Index (mSBI)		baseline, 6 and 9 months