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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Collaborator: National Institute of Health and Nutrition
• Treatments: Carotenoids; Lycopene

Criteria

Inclusion Criteria:

Type 2 diabetes

• Patients on oral hypoglycemic drugs with no modification in therapy from the past 12 months

• Chronic periodontitis as per AAP (American Academy of Periodontology) guidelines

• Minimum of 15 natural teeth

• At least four teeth with one or more sites with probing depth (PD) greater than or equal to 5 mm, clinical attachment level (CAL) greater than or equal to 4mm and bleeding on probing (BOP).

Exclusion Criteria:

History of antibiotic therapy within the previous 6 months

• History of anti-inflammatory drugs within the previous 3 months

• Pregnancy and lactation

• Use of contraceptives or any other form of hormone

• Usage of tobacco and tobacco related products

• Periodontal treatment within 12 months.