Assessment of Ozonated Sunflower Seed Oil Gel as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Grade B Periodontitis (Clinical and Laboratory Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
I) Patients:
The present study will be carried on periodontitis patients. The patients will be informed about the treatment steps. This includes the possible effects or risks, and other treatment options according to the rules of the Ethical Committee of Faculty of dentistry, Mansoura University.
Groups:
Group I (negative control): 15 periodontally healthy subjects. Group II (positive control): 15 patients will be treated with mechanical debridement only.
Group III (study group A): 15 patients will be treated with mechanical debridement followed by delivery of sunflower seed oil gel for each pocket. (J MAC BOTANICALS, organic cold pressed helianthus annuus sunflower seed oil, Waterglider LLC. Spokane Valley, WA 99216, USA).
Group IV (study group B): 15 patients will be treated with mechanical debridement followed by delivery of ozonated sunflower seed oil gel for each pocket.( PurO3, Ozonated Sunflower Oil combines organic sunflower oil and ozone, giving you an oxygen-rich, soothing gel with high amounts of ozone, 1220 S Happy Hollow Rd Fayetteville, AR 72701, USA).
Periodontal evaluation will be performed for all patients at baseline and after three months including the following parameters:
- Plaque index (PI).(15)
- Gingival index.(16)
- Probing pocket depth (PPD).(17)
- Clinical attachment level (CAL).(18) B) Gingival crevicular fluid sampling. C) Local drug delivery Adequate amount of prepared ozonated sunflower and sunflower oil gel will be delivered into the selected periodontal pockets.
B) Immunological analysis of TNF-α in GCF
详细描述
I) Patients:
The present study will be carried on periodontitis patients. The patient will be selected from Out Patient Clinic, Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology, Faculty of Dentistry, Mansoura University. The patients will be informed about the treatment steps. This includes the possible effects or risks, and other treatment options according to the rules of the Ethical Committee of Faculty of dentistry, Mansoura University. The patients must be legally competent to provide written consent before performing any required steps.
A)Inclusion Criteria
- Patients with Stage II Periodontitis grade B periodontitis (horizontal bone loss with maximum probing depth ≤ 5 mm and with 3-4 mm clinical attachment loss).
- Minimum of 20 remaining teeth.
- Age range (25 - 50) years.
- Good compliance with the plaque control instructions following initial therapy.
- Availability for follow up and maintenance program. B) Exclusion Criteria
1. Systemic diseases / drugs which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Stage II Periodontitis grade B periodontitis (horizontal bone loss with maximum probing depth ≤ 5 mm and with 3-4 mm clinical attachment loss).
- •Minimum of 20 remaining teeth.
- •Age range (25 - 50) years.
- •Good compliance with the plaque control instructions following initial therapy.
- •Availability for follow up and maintenance program.
排除标准
- •Systemic diseases / drugs which could influence the outcome of the therapy (According to Cornell Medical Index-Health Questionnaire).
- •Receiving periodontal therapy in past 6 month.
- •Pregnant and lactating females.
- •Vulnerable groups of patients (e.g handicapped patients and decisionally impaired individuals).
研究者
Ahmed Hashem Ahmed Alshareef
Bachelor 's degree, Faculty of Dentistry, Umm Alqura University, Saudi Arabia
Mansoura University