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

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Status and phase: Completed; Phase 4

Conditions: Positive Regulation of Oxidative Stress Process

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02263352

10/98/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Lycored soft gels , Scaling and Rootplaning.

Experimental group

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

Treatment:

Device: Scaling and root planing

Drug: Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day

Scaling and Rootplaning only.

Experimental group

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.

Treatment:

Device: Scaling and root planing