Evaluation of the Effects of an Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian traditional mouth rinse (Punica granatum Pleniflora or "Golnaar" mouthrinse) on treatment of diabetic gingivitis and compare it with chlorhexidine (0.2%).
详细描述
Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill other inclusion criteria, are randomly assigned to intervention or control groups. All of the patients will undergo a training panel about mouth hygiene and receive a pack of a toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2 weeks for the second evaluation and taking tooth bleaching. The demographic and general information of all participants are taken and the primary outputs (plaque index and bleeding on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the examinations are done by one trained person and patients, practitioner and statistical analyser are blind to the interventions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have gingivitis
- •Controlled diabetes mellitus [FBS<130mg/dl & Glycosilated hemoglobin (A1C)<7%]
- •Presence of gingivitis
- •Having at least 20 teeth
- •No history of hypersensitivity reaction
- •Age between 20 to 65 years
- •Agreement to participate in the study
排除标准
- •History of hypersensitivity reaction
- •Systemic diseases (Kidney, liver or rheumatologic diseases)
- •To have a pocket depth of more than 5
- •Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in the past 3 months and during the study period
研究组 & 干预措施
Chlorhexidine (0.2%)
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
干预措施: Chlorhexidine (0.2%) (Drug)
Chlorhexidine (0.2%)
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
干预措施: Tooth bleaching (Procedure)
Punica granatum Pleniflora mouth rinse
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
干预措施: Punica granatum Pleniflora (Golnaar) mouth rinse (Drug)
Punica granatum Pleniflora mouth rinse
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
干预措施: Tooth bleaching (Procedure)
结局指标
主要结局
Plaque Index
时间窗: At the beginning, after 2 weeks and after 4 weeks
0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Bleeding Index
时间窗: At the beginning, after 2 weeks and after 4 weeks.
presence of bleeding of the gum when probing it: 0= No bleeding 1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice
Pocket Depth
时间窗: At the beginning, after 2 weeks and after 4 weeks
It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).
Modified Gingival Index
时间窗: At the beginning, after 2 weeks and after 4 weeks.
0= Absence of inflammation 1. Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary 2. Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary 3. moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary 4. severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration
次要结局
- Number of Participants With Adverse Events(Up to 2 weeks)
- Satisfaction of Patients(Up to 2 week)
研究者
Mesbah Shams, MD
Associate professor of Internal Medicine & Endocrinology
Shiraz University of Medical Sciences