Status:
COMPLETED
A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
Lead Sponsor:
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Collaborating Sponsors:
National Institute of Health and Nutrition
Conditions:
Positive Regulation of Oxidative Stress Process
Eligibility:
All Genders
35-50 years
Phase:
PHASE4
Brief 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 mell...
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 chro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02263352
Start Date
January 1 2013
End Date
August 1 2013
Last Update
October 13 2014
Active Locations (1)
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1
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Hyderabad, India, 500060