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

Phase 4

Completed

• Conditions: Positive Regulation of Oxidative Stress Process
• Interventions: Device: Scaling and root planing; Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day

• Registration Number: NCT02263352
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-03
• Study Completion: 2013-08
• Status Verified: 2014-10
• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Study First Posted: 2014-10-13
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and Rootplaning only.	Scaling and root planing	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.
Lycored soft gels , Scaling and Rootplaning.	Scaling and root planing	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
Lycored soft gels , Scaling and Rootplaning.	Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day	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

Primary Outcome Measures

Name	Time	Method
Change in Serum MDA	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

Name	Time	Method
Change in Modified Gingival Index	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.
Change in Probing pocket depth (PPD)	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.
Change in Clinical attachment level (CAL)	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.

Trial Locations

Locations (1)

Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre; 🇮🇳 Hyderabad, India