Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis

Study Overview
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Brief Summary
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Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl

Detailed Description
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The study was designed as a randomized controlled clinical trial. Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing only. Group III: Included 8 patients with clinically healthy periodontium. Protein carbonyl biomarker level and clinical parameters were assisted to evaluate the effect of lycopene as an adjunct to scaling and root planing.

Official Title
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Gingival Crevicular Fluid Levels of Protein Carbonyl Oxidative Stress Biomarker Following the Use of Locally Delivered Lycopene Antioxidants in Patients With Chronic Periodontitis - Randomized Clinical Trial

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Lycopene + SRP
* Procedure: SRP only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects were free from any systemic diseases. Subjects for group I and II were suffering from severe chronic periodontitis (Armitage et al., 1999). Group III included subjects with clinically healthy periodontium. All subjects were between 35-60 years old. Both genders were included. Subjects were able to return for follow up visits. Subjects agreed to sign a written consent after the nature of the study was explained. Exclusion Criteria: History of scaling and root planing or periodontal surgery < 6 months prior to initiation of the study. History of administration of antimicrobial drugs or over the counter antioxidants like Vit C, Vit B, β-carotene < 6 months prior to the baseline examination. Subjects who reported any side effects or drug allergies from antioxidants. Subjects with mobile teeth, abscesses and defected restorations related to the affected sites. Subjects with para-functional habits. Pregnant and lactating females. Smokers, alcoholic and drug abusers. Prisoner. Mentally retarded patients.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing (SRP) and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing (SRP) only. Group III: Included 8 patients with clinically healthy periodontium.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I: Lycopene + SRP<br>Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing | Drug: Lycopene + SRP<br> <br> |
| Active Comparator: Group II: SRP only<br>Scaling and root planing only without lycopene | Procedure: SRP only<br> <br> |
| No Intervention: Group III: healthy subjects<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCF level of protein carbonyl | to assess GCF level of protein carbonyl following local delivery of sustained release form of lycopene as an adjunct to scaling and root planning (SRP) in management of severe chronic periodontitis patients. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index | To assess changes in plaque index following local delivery of stained release form of lycopene. | 6 months | 
| Modified gingival index | to assess changes in the gingival index following local delivery of sustained release form of lycopene. | 6 months | 
| Probing depth | To assess probing depth following local delivery of stained release form of lycopene. | 6 months | 
| Clinical attachment loss | To assess clinical attachment loss following local delivery of sustained release form of lycopene. | 6 minths | 
| Radiographic changes | to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene. | 6 months | 
| Drug release | to assess rate of lycopene release using high performance liquid chromatography technique (HPLC). | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lycopene, Chronic periodontitis, Protein carbonyl