Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02263352
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Collaborator:
National Institute of Health and Nutrition
Information provided by (Responsible Party):
Manasa Ambati, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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.

Condition or disease Intervention/treatment Phase
Positive Regulation of Oxidative Stress Process Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day Device: Scaling and root planing Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arm Intervention/treatment
Experimental: Lycored soft gels , Scaling and Rootplaning.
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
Lycopene 8mgms taken orally ,one per day for two months.
Other Name: rhodopurpurin,non-provitamin A carotenoid,

Device: Scaling 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
Other Name: Nonsurgical periodontal therapy, Conventional periodontal therapy.

Experimental: Scaling and Rootplaning only.
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
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
Other Name: Nonsurgical periodontal therapy, Conventional periodontal therapy.




Primary Outcome Measures :
  1. Change in Serum MDA [ Time Frame: 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 Outcome Measures :
  1. Change in Modified Gingival Index [ Time Frame: 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.

  2. Change in Probing pocket depth (PPD) [ Time Frame: 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.

  3. Change in Clinical attachment level (CAL) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263352


Locations
Layout table for location information
India
Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
Hyderabad, India, 500060
Sponsors and Collaborators
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
National Institute of Health and Nutrition
Investigators
Layout table for investigator information
Principal Investigator: Dr.Manasa Ambati, MDS(Perio) Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Manasa Ambati, Dr.Manasa Ambati, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT02263352     History of Changes
Other Study ID Numbers: 10/98/12
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by Manasa Ambati, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre:
Diabetes, Periodontitis, Oxidative stress, Antioxidant

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lycopene
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents