Comparative Evaluation of Propolis Mouthwash With 0.2% Chlorhexidine Mouthwash in Improving the Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in periodontal pocket depth.
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of Propolis mouthwash with 0.2% Chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the status of periodontal disease in peri-menopausal women.
The main question it aims to answer are:
- Will propolis mouthwash be equal to Chlorhexidine mouthwash in improving the periodontal status of perimenopausal women?
- Can neopterin be used as an indicator of periodontal disease.
Participants will be asked questions about their general health, menstrual health and oral health then scaling will be done. After that participants will give saliva sample by spitting in a given container. Participants will be divided into 2 groups for treatment and each group comprised of 51 participants.
Group 1: 20% Propolis mouthwash, twice a day for 6 weeks. Group 2: 0.2% chlorhexidine mouthwash, twice a day for 6 weeks.
详细描述
Patients who gave consent underwent oral examination and subjects with scores 3 and 4 according to the protocols described by the British Society of Periodontology were recruited into the study.
To evaluate the treatment outcome following periodontal parameters were assessed at baseline, 6 weeks and 12 weeks.
a) periodontal pocket depth b) clinical attachment loss c) bleeding on probing.
The development of mouthwash includes 2 steps i.e. extraction and formulation. i) Propolis extraction was carried out at the University of Karachi, and the propolis collected was authenticated by the Department of Pharmacognosy, Faculty of Pharmacy, University of Karachi.
ii) The formulation was done by the Department of Pharmacognosy at Ziauddin College of Pharmacology.
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, Care Provider)
盲法说明
As this is going to be a double-blind study, a third person will dispense the Propolis mouthwash (prepared in Ziauddin College of pharmacy) and Chlorhexidine mouthwash (commercially available) into dark-colored bottles of the same size and shape. The third person will code the bottles as A or B and seal the codes with the product name in envelopes accordingly.
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females of age 40-50 years.
- •Patients who are willing to receive treatment and give informed consent.
- •Patients with probing pocket depth (PPD) of 4mm - 5mm and clinical attachment loss (CAL) of 1-4 mm.
- •Presence of bleeding on probing (BOP).
- •Patients should not have been subject to periodontal therapy and antibiotic medication in the past 6 months.
- •Patients with a minimum of 20 teeth in the oral cavity.
排除标准
- •Patients who are allergic to honey products.
- •Patients on HRT (hormone replacement therapy) or patients who have not had a menstrual cycle for the last 12 months.
- •Patients who had lost teeth because of periodontal disease.
- •Patients who are or have been smokers in the past.
- •Patients are on any kind of antibiotic therapy at the time of screening.
- •Systemic conditions predispose patients to chronic periodontal diseases such as diabetes.
研究组 & 干预措施
propolis
5 ml of 20% propolis mouthwash twice a day.
干预措施: Propolis mouthwash (Drug)
chlorhexidine
5 ml of 0.2% chlorhexidine mouthwash twice a day.
干预措施: Chlorhexidine mouthwash (Drug)
结局指标
主要结局
Change in periodontal pocket depth.
时间窗: baseline,6 weeks, 12 weeks.
Measured in mm using calibrated williams periodontal probe.
change in Bleeding on probing.
时间窗: baseline,6 weeks, 12 weeks
Presence or absence of blood in gingival pockets on probing.
Change in clinical attachment loss.
时间窗: baseline,6 weeks, 12 weeks
Measured in mm using calibrated williams periodontal probe.
次要结局
- Change in salivary neopterin levels.(baseline and 12 weeks.)
研究者
Dr. Maliha Waqar
Principal Investigstor
Ziauddin University