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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lycopene + SRP
SRP only
Sponsored by
Maie Sami tawfik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Lycopene, Chronic periodontitis, Protein carbonyl

Eligibility Criteria

35 Years - 52 Years (Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Group I: Lycopene + SRP

    Group II: SRP only

    Group III: healthy subjects

    Arm Description

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

    Scaling and root planing only without lycopene

    No intervention

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Plaque index
    To assess changes in plaque index following local delivery of stained release form of lycopene.
    Modified gingival index
    to assess changes in the gingival index following local delivery of sustained release form of lycopene.
    Probing depth
    To assess probing depth following local delivery of stained release form of lycopene.
    Clinical attachment loss
    To assess clinical attachment loss following local delivery of sustained release form of lycopene.
    Radiographic changes
    to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.
    Drug release
    to assess rate of lycopene release using high performance liquid chromatography technique (HPLC).

    Full Information

    First Posted
    June 24, 2017
    Last Updated
    June 28, 2017
    Sponsor
    Maie Sami tawfik
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03203746
    Brief Title
    Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 28, 2015 (Actual)
    Primary Completion Date
    November 10, 2016 (Actual)
    Study Completion Date
    December 14, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Maie Sami tawfik

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Lycopene, Chronic periodontitis, Protein carbonyl

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    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)
    Masking Description
    No masking
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I: Lycopene + SRP
    Arm Type
    Experimental
    Arm Description
    Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing
    Arm Title
    Group II: SRP only
    Arm Type
    Active Comparator
    Arm Description
    Scaling and root planing only without lycopene
    Arm Title
    Group III: healthy subjects
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Lycopene + SRP
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP only
    Primary Outcome Measure Information:
    Title
    GCF level of protein carbonyl
    Description
    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.
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Plaque index
    Description
    To assess changes in plaque index following local delivery of stained release form of lycopene.
    Time Frame
    6 months
    Title
    Modified gingival index
    Description
    to assess changes in the gingival index following local delivery of sustained release form of lycopene.
    Time Frame
    6 months
    Title
    Probing depth
    Description
    To assess probing depth following local delivery of stained release form of lycopene.
    Time Frame
    6 months
    Title
    Clinical attachment loss
    Description
    To assess clinical attachment loss following local delivery of sustained release form of lycopene.
    Time Frame
    6 minths
    Title
    Radiographic changes
    Description
    to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.
    Time Frame
    6 months
    Title
    Drug release
    Description
    to assess rate of lycopene release using high performance liquid chromatography technique (HPLC).
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Y Gamal, PhD
    Organizational Affiliation
    AinShams university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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