Clinical trial NCT02263352: A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
Official title: Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Positive Regulation of Oxidative Stress Process
Keywords: Diabetes, Periodontitis, Oxidative stress, Antioxidant
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
Collaborators: name: National Institute of Health and Nutrition
First posted: 2014-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Change in Serum MDA
timeFrame: 6 Months Post treatment.
Secondary outcomes:
measure: Change in Modified Gingival Index
timeFrame: 6 Months post treatment.
measure: Change in Probing pocket depth (PPD)
timeFrame: 6 Months post treatment.
measure: Change in Clinical attachment level (CAL)
timeFrame: 6 Months post treatment.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Study officials:
affiliation: Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.
name: Dr.Manasa Ambati, MDS(Perio)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neyestani TR, Shariatzadeh N, Gharavi A, Kalayi A, Khalaji N. Physiological dose of lycopene suppressed oxidative stress and enhanced serum levels of immunoglobulin M in patients with Type 2 diabetes mellitus: a possible role in the prevention of long-term complications. J Endocrinol Invest. 2007 Nov;30(10):833-8. doi: 10.1007/BF03349224.
citation: Chandra RV, Prabhuji ML, Roopa DA, Ravirajan S, Kishore HC. Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial. Oral Health Prev Dent. 2007;5(4):327-36.
citation: Cohen DW, Friedman LA, Shapiro J, Kyle GC, Franklin S. Diabetes mellitus and periodontal disease: two-year longitudinal observations. I. J Periodontol. 1970 Dec;41(12):709-12. doi: 10.1902/jop.1970.41.12.709. No abstract available.