Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis (A Clinical and Biochemical Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
This study aimed to assess clinically and biochemically the effect of intrapocket application of tea tree oil (TTO) gel adjunctive to SRP in the management of stage 2(moderate) periodontitis and to correlate the biochemical levels with clinical response.
详细描述
A randomized, controlled clinical trial included thirty patients with stage 2 periodontitis. They were equally divided into two groups: Group 1 (control group) treated with scaling and root planning (SRP) alone and Group 2 (test group) managed by SRP and locally delivered 5% tea tree oil (TTO) gel.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with stage 2,grade B periodontitis according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- •Patients with CAL 3-4 mm , BOP and radiographic horizontal bone loss related to the coronal third of the root (15%-33%).
- •Patients with no teeth loss due to periodontitis.
- •Patients with radiographic bone loss/age % of 0.25-1 %.
- •Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study.
排除标准
- •Patients with CAL caused by non periodontal causes.
- •Patients with grade C periodontitis.
- •Patients having any systemic disease that may affect the treatment outcomes
- •Pregnant females.
- •Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.
研究组 & 干预措施
Scaling and Root Planing (SRP)
干预措施: Scaling and Root Planing (Procedure)
Scaling and Root Planing with tea tree oil
干预措施: Scaling and Root Planing with tea tree oil (Drug)
结局指标
主要结局
Probing depth
时间窗: up to 6 months
Probing depth was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.
Clinical attachment loss
时间窗: up to 6 months
Clinical attachment loss was recorded at tested sites with graduated William's probe graduated in 1 mm increment. Readings were rounded to the nearest mm.
Biochemical assessment of inlammation
时间窗: up to 6 months
This involved determination of the gingival crevicular fluid (GCF) levels of matrix metalloproteinase 8 (MPP-8). A GCF sample was taken from the area showing the deepest pocket depth around the treated area.The samples were diluted in phosphate buffer saline (PBS) up to 1 mL. After waiting for 15 min, the paper points were removed, and 500 μL were centrifuged at 400 g for 4 min, then frozen at -20°C pending MMP-8 analysis using Human Matrix metalloproteinase 8/Neutrophil collagenase (MMP-8) ELISA Kit according to the manufacturer instructions.
Bleeding on probing
时间窗: up to 6 months
Bleeding on probing was assessed at tested sites with graduated William's probe graduated in 1 mm increment, within 15 seconds after probing, using a dichotomous scoring system (+ and -) for presence or absence, respectively.
次要结局
未报告次要终点
研究者
Maha Talaab
Associate Professor, Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology department
Alexandria University