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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Positive Regulation of Oxidative Stress Process

Intervention / Treatment
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* Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day
* Device: Scaling and root planing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lycored soft gels , Scaling and Rootplaning.<br>Systemic Lycored soft gels,(Jagsonpal Pharma) was given orally 8mgms/day for 2 months and Scaling and rootplaning (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) which was performed at baseline | Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day<br>* Lycopene 8mgms taken orally ,one per day for two months.<br>* Other names: rhodopurpurin,non-provitamin A carotenoid,;Device: Scaling and root planing<br>* 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<br>* Other names: Nonsurgical periodontal therapy, Conventional periodontal therapy.;|
| Experimental: Scaling and Rootplaning only.<br>Scaling and rootplaning(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) which was performed at baseline. | Device: Scaling and root planing<br>* 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<br>* Other names: Nonsurgical periodontal therapy, Conventional periodontal therapy.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum MDA | This unique outcome measure was assessed from baseline to 6 months post treatment by spectrophotometric estimation of serum Thiobarbituric acid substances (TBARS). The TBARS Assay measures malondialdehyde (MDA), a reactive compound formed from lipid peroxides that are generated under conditions of oxidative stress. Oxidative modification of lipids occurs with aging and various diseases, and increased oxidative stress is associated with diabetes and its complications. MDA forms an adduct with thiobarbituric acid (TBA). Results are calculated from a standard curve constructed with authentic MDA. | 6 Months Post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Gingival Index | The change in Modified gingival index from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe. | 6 Months post treatment. | 
| Change in Probing pocket depth (PPD) | The change in Probing pocket depth from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe. | 6 Months post treatment. | 
| Change in Clinical attachment level (CAL) | The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe. | 6 Months post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Periodontitis, Oxidative stress, Antioxidant