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

Maie Sami tawfik

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Periodontitis

Treatments: Drug: Lycopene + SRP; Procedure: SRP only

Study type: Interventional

Funder types: Other

Identifiers

NCT03203746

Maie Sami

Details and patient eligibility

About

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

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 35 to 52 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group I: Lycopene + SRP

Experimental group

Description:

Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing

Treatment:

Drug: Lycopene + SRP

Group II: SRP only

Active Comparator group

Description:

Scaling and root planing only without lycopene

Treatment:

Procedure: SRP only

Group III: healthy subjects

No Intervention group

Description:

No intervention