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

NCT02263352 | Completed Phase 4 DMC

• 1 other identifier: 10/98/12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Positive Regulation of Oxidative Stress Process

Keywords

Diabetes, Periodontitis, Oxidative stress, Antioxidant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Modified Gingival Index

  6 Months post treatment.

• Change in Probing pocket depth (PPD)

  6 Months post treatment.

• Change in Clinical attachment level (CAL)

  6 Months post treatment.

Study Arms (2)

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

Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day; Device: Scaling and root planing

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.

Device: Scaling and root planing

Interventions

Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day DRUG

Lycopene 8mgms taken orally ,one per day for two months.

Also known as: rhodopurpurin,non-provitamin A carotenoid,

Lycored soft gels , Scaling and Rootplaning.

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

Also known as: Nonsurgical periodontal therapy, Conventional periodontal therapy.

Lycored soft gels , Scaling and Rootplaning.; Scaling and Rootplaning only.

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead
• National Institute of Health and Nutrition: collaborator

Study Sites (1)

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Hyderabad, 500060, India

Location

Related Publications (3)

• 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.

  PMID: 18075285 BACKGROUND

• 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.

  PMID: 18173095 BACKGROUND

• 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.

  PMID: 5275715 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Periodontitis

Interventions

Weights and Measures; Root Planing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Dr.Manasa Ambati, MDS(Perio)

  Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,Road no:5,Kamala nagar,Dilsukhnagar,Hyderabad,India.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Manasa Ambati

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 13, 2014
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

IN (1)