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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- GCF level of protein carbonyl
研究概览
简要总结
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 35 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group I: Lycopene + SRP
Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing
干预措施: Lycopene + SRP (Drug)
Group II: SRP only
Scaling and root planing only without lycopene
干预措施: SRP only (Procedure)
结局指标
主要结局
GCF level of protein carbonyl
时间窗: 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.
次要结局
- Plaque index(6 months)
- Modified gingival index(6 months)
- Probing depth(6 months)
- Clinical attachment loss(6 minths)
- Radiographic changes(6 months)
- Drug release(1 month)
研究者
Maie Sami tawfik
Principal investigator
Ain Shams University