A Clinical Study Comparing the Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash With Chlorhexidine Mouthwash in a 14-Day Experimental Gingivitis Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
研究概览
简要总结
Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little research has been carried out to determine its true clinical significance on periodontal health. The purpose of this study is to evaluate and compare the efficacy of 1% myrrh mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.
详细描述
This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on probing < 10%). We will include all eligible patients seeking dental treatment at the center after gaining a written informed consent. After the initial dental screening and a session of professional teeth cleaning procedures, participants will be instructed to refrain from regular oral hygiene practices for 2 weeks to develop experimental gingivitis. Participants will then be randomly allocated to one of the three treatment groups [1:1:1] using a simple randomization method (i.e. computer-generated random numbers). They will be instructed to continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash twice daily for 1 minute. Treatment effect will be evaluated by comparing the baseline (day 0) and post-intervention (day 14) values of all clinical parameters (modified gingival index, plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good periodontal health;
- •dentition of ≥20 teeth and a minimum of 5 teeth per quadrant;
- •the absence of any systemic illness;
- •no history of oral prophylaxis in the past 6 months;
- •no relevant medical history that might compromise normal oral hygiene practice.
排除标准
- •pocket depth >3 mm
- •severe misalignment of teeth;
- •the presence of orthodontic appliances;
- •intake of antibiotic and/or anti-inflammatory medications within the past 6 months;
- •use of tobacco;
- •inability of comply with the study's appointment schedule;
- •pregnant or breast-feeding mothers.
研究组 & 干预措施
Myrrh mouthwash
1% mouthwash of Commiphora myrrha made from resin extract. Participants will use 10 ml of the mouthwash twice daily for 14 days.
干预措施: Myrrh mouthwash (Drug)
Chlorhexidine Mouthwash
Commercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh). Participants will use 10 ml of the mouthwash twice daily for 14 days.
干预措施: Chlorhexidine mouthwash (Drug)
Normal saline
Commercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah). Participants will use 10 ml of the mouthwash twice daily for 14 days.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
时间窗: Baseline and Day 14
IL-1β is an important mediator of the inflammatory response. Elevated IL-1β levels have been reported in a number of infectious disease conditions and in noninfectious inflammatory conditions. Human IL-1β ELISA kit by BioVendor was utilized to determine the IL-1β level. Preparation of reagents, execution of test protocol, and calculation of results were done adhering to the manufacturer's Product Data Sheet enclosed with the kit. The absorbance of each strip was read on a spectro-photometer at 450 nm wave length.
次要结局
- Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14(Baseline, Day 7, and Day 14)
- Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14(Baseline, Day 7, and Day 14)
- Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14(Baseline and Day 14)
研究者
talal zahid
Associate Professor
King Abdulaziz University