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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Positive Regulation of Oxidative Stress Process

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day

Intervention Type DRUG

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

Scaling and root planing

Intervention Type 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

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.

Group Type EXPERIMENTAL

Scaling and root planing

Intervention Type 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

Interventions

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Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day

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

Intervention Type DRUG

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

Intervention Type DEVICE

Other Intervention Names

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rhodopurpurin,non-provitamin A carotenoid, Nonsurgical periodontal therapy, Conventional periodontal therapy.

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No