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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Conditions
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
SRP only
ProcedurePrimary outcomes
-
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
-
Plaque index
Time frame: 6 months
To assess changes in plaque index following local delivery of stained release form of lycopene.
-
Modified gingival index
Time frame: 6 months
to assess changes in the gingival index following local delivery of sustained release form of lycopene.
-
Probing depth
Time frame: 6 months
To assess probing depth following local delivery of stained release form of lycopene.
-
Clinical attachment loss
Time frame: 6 minths
To assess clinical attachment loss following local delivery of sustained release form of lycopene.
-
Radiographic changes
Time frame: 6 months
to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene.
-
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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