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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203746
• Other study ID #: Maie Sami
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 24, 2017
• Last updated: June 28, 2017
• Start date: September 28, 2015
• Est. completion date: December 14, 2016

Study information

• Verified date: June 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 14, 2016
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 52 Years

Eligibility

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, ß-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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Lycopene + SRP

Procedure:
• SRP only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maie Sami tawfik

Outcome

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