Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Clinical attachment level
研究概览
简要总结
The goal of this split-mouth clinical trial is to evaluate the effects of Manuka honey applied into periodontal pockets after initial periodontal therapy (NSPT) in the treatment of stage 3 periodontitis.
The main question it aims to answer is:
• does the adjunct of Manuka honey improve the outcome of the non-surgical periodontal treatment.
The intervention in this study was conducted in a split-mouth design, meaning that after completing the NSPT for each subject, Manuka honey was administered as an adjunct to the periodontal treatment in two randomly selected quadrants of the oral cavity around the teeth with a specially designed cannula.
This was followed by oral hygiene instructions and training. The home-performed oral hygiene procedures were focused on interdental cleaning using dental floss and toothbrushing with regular fluoride-containing toothpaste. The subjects were also instructed not to use any form of oral antiseptic (e.g., chlorhexidine) or antibiotic during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both genders with good systemic health;
- •Non-smokers;
- •Presence of at least 20 teeth;
- •Untreated moderate to advanced generalized chronic periodontitis according to the 1999 Classification 199 , i.e., generalized stage III periodontitis according to the 2007 Classification
排除标准
- •Pregnant and nursing women;
- •Antibiotics prescribed for dental or non-dental diseases 6 months before the start of the research;
- •Systemic diseases or the use of drugs known to affect periodontal tissues, bleeding parameters;
- •Acute oral or periodontal inflammation or infection (pericoronitis, necrotizing periodontal diseases, etc.).
结局指标
主要结局
Clinical attachment level
时间窗: Baseline: 12 months
Evaluation of changes in terms of clinical attachment gain
Periodontal pocket depth
时间窗: Baseline; 12 months
Evaluation of changes of periodontal pocket depth
次要结局
未报告次要终点
研究者
Darko Bozic
Associate professor of Periodontology
University of Zagreb