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Completed

NCT Number: NCT03203746

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

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

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Key information

Age range

35 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lycopene + SRP

Drug

SRP only

Procedure

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Maie Sami tawfik

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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