Positive Regulation of Oxidative Stress Process
Conditions
Keywords
Diabetes, Periodontitis, Oxidative stress, Antioxidant
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.
Interventions
DRUGLycored soft gels Jagsonpal Pharma, Systemic 8mgms/day
Lycopene 8mgms taken orally ,one per day for two months.
DEVICEScaling and root planing
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
Sponsors
National Institute of Health and Nutrition
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum MDA | 6 Months Post treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Gingival Index | 6 Months post treatment. | 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. |
| Change in Probing pocket depth (PPD) | 6 Months post treatment. | 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. |
| Change in Clinical attachment level (CAL) | 6 Months post treatment. | The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe. |
Countries
India
Outcome results
None listed