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Trial record 11 of 312 for:    "Periodontitis, Chronic"

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

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ClinicalTrials.gov Identifier: NCT03203746
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Maie Sami tawfik, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Lycopene + SRP Procedure: SRP only Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
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
Actual Study Start Date : September 28, 2015
Actual Primary Completion Date : November 10, 2016
Actual Study Completion Date : December 14, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

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



Primary Outcome Measures :
  1. GCF level of protein carbonyl [ Time Frame: 1 month ]
    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 :
  1. Plaque index [ Time Frame: 6 months ]
    To assess changes in plaque index following local delivery of stained release form of lycopene.

  2. Modified gingival index [ Time Frame: 6 months ]
    to assess changes in the gingival index following local delivery of sustained release form of lycopene.

  3. Probing depth [ Time Frame: 6 months ]
    To assess probing depth following local delivery of stained release form of lycopene.

  4. Clinical attachment loss [ Time Frame: 6 minths ]
    To assess clinical attachment loss following local delivery of sustained release form of lycopene.

  5. Radiographic changes [ Time Frame: 6 months ]
    to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.

  6. Drug release [ Time Frame: 1 month ]
    to assess rate of lycopene release using high performance liquid chromatography technique (HPLC).



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Ages Eligible for Study:   35 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203746


Sponsors and Collaborators
Maie Sami tawfik
Investigators
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Study Director: Ahmed Y Gamal, PhD AinShams university

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Responsible Party: Maie Sami tawfik, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03203746     History of Changes
Other Study ID Numbers: Maie Sami
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maie Sami tawfik, Ain Shams University:
Lycopene
Chronic periodontitis
Protein carbonyl

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Lycopene
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents