Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lycopene + SRP
SRP only
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Lycopene, Chronic periodontitis, Protein carbonyl
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Group I: Lycopene + SRP
Group II: SRP only
Group III: healthy subjects
Arm Description
Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing
Scaling and root planing only without lycopene
No intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plaque index
To assess changes in plaque index following local delivery of stained release form of lycopene.
Modified gingival index
to assess changes in the gingival index following local delivery of sustained release form of lycopene.
Probing depth
To assess probing depth following local delivery of stained release form of lycopene.
Clinical attachment loss
To assess clinical attachment loss following local delivery of sustained release form of lycopene.
Radiographic changes
to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.
Drug release
to assess rate of lycopene release using high performance liquid chromatography technique (HPLC).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03203746
Brief Title
Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 28, 2015 (Actual)
Primary Completion Date
November 10, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maie Sami tawfik
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Lycopene, Chronic periodontitis, Protein carbonyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I: Lycopene + SRP
Arm Type
Experimental
Arm Description
Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing
Arm Title
Group II: SRP only
Arm Type
Active Comparator
Arm Description
Scaling and root planing only without lycopene
Arm Title
Group III: healthy subjects
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Lycopene + SRP
Intervention Type
Procedure
Intervention Name(s)
SRP only
Primary Outcome Measure Information:
Title
GCF level of protein carbonyl
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Plaque index
Description
To assess changes in plaque index following local delivery of stained release form of lycopene.
Time Frame
6 months
Title
Modified gingival index
Description
to assess changes in the gingival index following local delivery of sustained release form of lycopene.
Time Frame
6 months
Title
Probing depth
Description
To assess probing depth following local delivery of stained release form of lycopene.
Time Frame
6 months
Title
Clinical attachment loss
Description
To assess clinical attachment loss following local delivery of sustained release form of lycopene.
Time Frame
6 minths
Title
Radiographic changes
Description
to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.
Time Frame
6 months
Title
Drug release
Description
to assess rate of lycopene release using high performance liquid chromatography technique (HPLC).
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Y Gamal, PhD
Organizational Affiliation
AinShams university
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gingival Crevicular Fluid Levels of Protein Carbonyl Following the Use of Lycopene in Chronic Periodontitis
We'll reach out to this number within 24 hrs