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

NCT03203746 | Completed Phase 1

• 1 other identifier: Maie Sami
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Periodontitis

Keywords

Lycopene; Chronic periodontitis; Protein carbonyl

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (6)

• Plaque index

  6 months

• Modified gingival index

  6 months

• Probing depth

  6 months

• Clinical attachment loss

  6 minths

• Radiographic changes

  6 months

Study Arms (3)

Group I: Lycopene + SRP

EXPERIMENTAL

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

Drug: Lycopene + SRP

Group II: SRP only

ACTIVE COMPARATOR

Scaling and root planing only without lycopene

Procedure: SRP only

Group III: healthy subjects

NO INTERVENTION

No intervention

Interventions

Lycopene + SRP DRUG

Group I: Lycopene + SRP

SRP only PROCEDURE

Group II: SRP only

Eligibility Criteria

• Age: 35 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maie Sami tawfik: lead

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Ahmed Y Gamal, PhD

  AinShams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: June 29, 2017
• Study Start: September 28, 2015
• Primary Completion: November 10, 2016
• Study Completion: December 14, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share