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NCT Number: NCT02263352

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

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.

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Key information

Conditions

Positive Regulation of Oxidative Stress Process Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre

Hyderabad, 500060, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day

Drug

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

Other names: rhodopurpurin,non-provitamin A carotenoid,

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

Other names: Nonsurgical periodontal therapy, Conventional periodontal therapy.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Other

Collaborators

  • National Institute of Health and Nutrition

Registry information

Official study title

Systemic Lycopene as an Adjunct to Scaling and Rootplaning in Chronic Periodontitis Patients With Type 2 Diabetes Mellitus

Acronym: "SLSRPD"

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 13, 2014
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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