Effects of Moringa Oleifera Mouthwash in Patients Undergoing Fixed Orthodontic Appliance Treatment: a Parallel Arm, Triple Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Modified Gingival Index
研究概览
简要总结
Improvement of oral hygiene maintenance is very important during fixed orthodontic appliance treatment to prevent the degenerative effects. Different mouthwashes are available in market but this study is being conducted to check the effects of Moring Oleifera mouth wash against the development of Gingivitis, Periodontitis, Plaque formation, Enamel Demineralization /white spot lesion, discoloration and bacterial load in dental plaque during the fixed orthodontic treatment.
详细描述
With the increase in desire of improved facial and dental aesthetics among all social classes, the numbers of cases being treated with fixed orthodontic appliances are increasing. It is difficult to maintain certain standard of oral hygiene with the braces on, so the iatrogenic degenerative effects of fixed orthodontic appliances are somewhat inevitable. Along with proper brushing and flossing orthodontists advise the use of mouthwash as well in order to prevent or lessen the severity of gingivitis, periodontitis, gingival hyperplasia, demineralization, white spot lesions, discoloration of teeth etc.
Plenty of mouth washes are available in market containing varying concentration of different chemicals promising to improve the oral health and reduce inflammation. But all of them having certain side effects most common being the discoloration. The focus is being shifted to natural ingredients to gain the same or even better results with minimum to zero side effects. In quest of getting closer to Mother Nature Moringa Oleifera leaf was discovered in 1785 in Indian Subcontinent.
Moringa Oleifera is a nutraceutical and well known for its anti-inflammatory, anti-microbial, anti-cancer, anti-diabetes, anti-rheumatoid arthritis, hepatoprotective, Steroid-genesis modulators and neuroprotective functions and many other properties. Its leaves evidently contain various natural anti-inflammatory and anti-oxidant substances namely flavonoid, phenolic and carotenoid. Besides, MO leaves also rich in protein, vitamin C, vitamin A, calcium and potassium. Flavonoids may act as antioxidant by scavenging free radical and protecting the cell from oxidative stress. Recently quite a lot work has been done on flavonoids in dentistry which includes anti-bacterial/anti-cariogenic effects, reduction in plague formation, Treatment in surgical wounds, reduction in dentinal hypersensitivity, treatment of periodontitis and gingivitis because of its anti-inflammatory and anti-oxidative effects.
Previously studies have been done to check the efficacy of different herbal mouthwashes but no study has been done to check the efficacy of MO leaf extract mouth wash on the oral health of the patients having fixed orthodontic treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young healthy subjects undergoing orthodontic treatment.
- •Patients with all permanent teeth present without any oral pathology.
- •Healthy gingiva with no bleeding on probing before start of orthodontic treatment and a normal pocket depth (1-3mm) on all teeth.
- •No WSLs (score = 1
排除标准
- •History of smoking, patients suffering from any systemic illness like diabetes.
- •Gingivitis or an active periodontal disease.
- •Carious lesions on labial/buccal surface of teeth.
- •Mentally handicapped individuals
结局指标
主要结局
Modified Gingival Index
时间窗: 7 months
Changes from the baseline, gingivitis will be assessed using this index graded from0-4, 0= Normal, 1=Mild inflammation, slight change in color, little change in texture of any portion of gingival unit. 2= Mild inflammation of entire gingival unit. 3=Moderate inflammation of entire gingival unit. 4=Severe inflammation of entire gingival unit.
Plaque Index
时间窗: 7 months
Changes from base line, quantity of plaque will be assessed using plaque index, graded from 0-4, 0=Absence of microbial plaque. 1=Thin film of microbial plaque along the free gingival margin. 2=Moderate accumulation with plaque in the sulcus. 3=Large amount of plaque in sulcus or pocket along the free gingival margin.
White spot Lesions
时间窗: 7 months
Changes from the baseline, white spot lesions will be assessed visually by grading from 1-4. 1= Normal, 2= Slight, 3= Severe, 4= Cavitation.
Discoloration of teeth
时间窗: 7 months
Changes from the baseline, discoloration will be assessed by taking photographs on every interval using the same camera at the same settings. these photographs will be assessed from by 2 panels 2 weeks apart.
Bacterial Load In Plaque
时间窗: 3 months
Changes from the baseline, Colony forming units will be measured by doing microbial analysis. Quantity of CFUs for S. mutans and P. Gingivalis will be used.
Periodontal Probing Depth
时间窗: 7 months
Changes from baseline, the probing depth scale will be used to assess the pocket depth, and is graded from 0-5, 0= no No pockets\>3.5mm, no calculus/overhangs, no bleeding after probing(black band completely visible). 1=No pockets\>3.5mm, no calculus/overhangs, but bleeding after probing(black band completely visible). 2= No pockets\>3.5mm, but supra or subgingival calculus/overhangs(black band completely visible). 3=Probing depth 3.5-5.5mm (black band partially visible, indicating pocket of 4-5mm). 4=Probing depth\> 5.5mm (black band entirely within pocket, indicating pocket of 6mm or more). 5=Furcation involvement.
次要结局
未报告次要终点