Back to resultsA Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus ("SLSRPD")
Primary Purpose
Positive Regulation of Oxidative Stress Process
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day
Scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Positive Regulation of Oxidative Stress Process focused on measuring Diabetes, Periodontitis, Oxidative stress, Antioxidant
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.
Sites / Locations
- Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lycored soft gels , Scaling and Rootplaning.
Scaling and Rootplaning only.
Arm Description
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(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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02263352
First Posted
October 1, 2014
Last Updated
October 8, 2014
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Collaborators
National Institute of Health and Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT02263352
Brief Title
A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
Acronym
"SLSRPD"
Official Title
Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Collaborators
National Institute of Health and Nutrition
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive Regulation of Oxidative Stress Process
Keywords
Diabetes, Periodontitis, Oxidative stress, Antioxidant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lycored soft gels , Scaling and Rootplaning.
Arm Type
Experimental
Arm Description
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
Arm Title
Scaling and Rootplaning only.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day
Other Intervention Name(s)
rhodopurpurin,non-provitamin A carotenoid,
Intervention Description
Lycopene 8mgms taken orally ,one per day for two months.
Intervention Type
Device
Intervention Name(s)
Scaling and root planing
Other Intervention Name(s)
Nonsurgical periodontal therapy, Conventional periodontal therapy.
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Serum MDA
Description
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.
Time Frame
6 Months Post treatment.
Secondary Outcome Measure Information:
Title
Change in Modified Gingival Index
Description
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.
Time Frame
6 Months post treatment.
Title
Change in Probing pocket depth (PPD)
Description
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.
Time Frame
6 Months post treatment.
Title
Change in Clinical attachment level (CAL)
Description
The change in CAL from baseline to 6 months post treatment was assessed full mouth at 6 sites /tooth with Hufreidy Periodontal probe.
Time Frame
6 Months post treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Manasa Ambati, MDS(Perio)
Organizational Affiliation
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
City
Hyderabad
ZIP/Postal Code
500060
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
18075285
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.
Results Reference
background
PubMed Identifier
18173095
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.
Results Reference
background
PubMed Identifier
5275715
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.
Results Reference
result
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A Clinical Trial to Study the Effect of Lycopene in Patients With Gum Disease and type2 Diabetes Mellitus
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