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

NCT ID: NCT03203746

Last Updated: 2017-06-29

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

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-28

Study Completion Date

2016-12-14

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.

Conditions

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Chronic Periodontitis

Keywords

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Lycopene Chronic periodontitis Protein carbonyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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Group I: Lycopene + SRP

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

Group Type EXPERIMENTAL

Lycopene + SRP

Intervention Type DRUG

Group II: SRP only

Scaling and root planing only without lycopene

Group Type ACTIVE_COMPARATOR

SRP only

Intervention Type PROCEDURE

Group III: healthy subjects

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lycopene + SRP

Intervention Type DRUG

SRP only

Intervention Type PROCEDURE

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maie Sami tawfik

OTHER

Sponsor Role lead

Responsible Party

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Maie Sami tawfik

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Y Gamal, PhD

Role: STUDY_DIRECTOR

AinShams university

Other Identifiers

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Maie Sami

Identifier Type: -

Identifier Source: org_study_id