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| Name | Class |
|---|---|
| National Institute of Health and Nutrition | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lycored soft gels , Scaling and Rootplaning. | Experimental | 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 |
|
| Scaling and Rootplaning only. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day | Drug | Lycopene 8mgms taken orally ,one per day for two months. |
|
| 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. |
| 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) |
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Inclusion Criteria:
Type 2 diabetes
Exclusion Criteria:
History of antibiotic therapy within the previous 6 months
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Manasa Ambati, MDS(Perio) | Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre | Hyderabad | 500060 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18075285 | Background | 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. | |
| 18173095 |
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| Scaling and root planing | Device | 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 |
|
|
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. |
| 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. |
| 5275715 | Result | 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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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