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

June 28, 2017 updated by: Maie Sami tawfik

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 52 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maie Sami tawfik

Investigators

  • Study Director: Ahmed Y Gamal, PhD, Ainshams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2015

Primary Completion (ACTUAL)

November 10, 2016

Study Completion (ACTUAL)

December 14, 2016

Study Registration Dates

First Submitted

June 24, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (ACTUAL)

June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maie Sami

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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