NCT02263352

A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus

Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre · Academic / Other
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus.

Detailed description

This study is a randomized double blinded clinical trial which was performed to assess the efficacy of systemic lycopene (8 mgms Daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. The primary outcome measures were Serum MDA, CRP and Hb1AC. The secondary outcomes were modified gingival index(GI), Probing pocket depth(PPD), and Clinical attachment level(CAL). All the outcomes were measured at baseline, 2 months and 6 months. The results were that the Lycopene with scaling and root planing group gave: Statistically significant results in reducing Mean serum MDA levels at 2 months and 6 months respectively.

Conditions

• Positive Regulation of Oxidative Stress Process

Interventions

Type	Name	Description
DRUG	Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day	Lycopene 8mgms taken orally ,one per day for two months.
DEVICE	Scaling and root planing	Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2014-10-13
• Last updated: 2014-10-13

Locations

1 site across 1 country: India