| Trial ID: | L5720 |
| Source ID: | NCT02263352
|
| Associated Drug: |
Lycored Soft Gels Jagsonpal Pharma, Systemic 8mgms/Day
|
| Title: |
A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
|
| Acronym: |
"SLSRPD"
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Positive Regulation of Oxidative Stress Process
|
| Interventions: |
DRUG: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day|DEVICE: Scaling and root planing
|
| Outcome Measures: |
Primary: 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: 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.
|
| Sponsor/Collaborators: |
Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre | Collaborators: National Institute of Health and Nutrition
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2013-08
|
| Results First Posted: |
|
| Last Update Posted: |
2014-10-13
|
| Locations: |
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre, Hyderabad, 500060, India
|
| URL: |
https://clinicaltrials.gov/show/NCT02263352
|
