Role of individualized Homoeopathy in treatment of gingivitis in school children aged 10-16 years-A pilot single blind randomized placebo control trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Gingival index
研究概览
简要总结
Gingivitisis an inflammatory condition of gums. The symptoms of gingivitis are swelling, redness, halitosis, bleeding gums often associated while brushing the teeth. The most common form of gingivitis occurs due to bacterial biofilms on tooth surfaces known as plaque .Plaque accumulation is seen mostly along the cervical margins and is the result of poor oral hygiene. Other causes associated with gingivitis are systemic, hereditary, hormonal, viral, fungal infections and nutritional deficiencies. The prevalence and severity of gingivitis in school students aged 6–11 years in Jordan is 38.5 % mild gingivitis, 31.4 % moderate gingivitis and 0.3 % severe gingivitis.
Gingivitis can be prevented through regular oral hygiene, brushing, mouth washes and toothpaste containing triclosan. Plaque when hardens forms calculus which can only be removed by dental professionals through scaling, root planning, curettage and mouth washes. Gingivitis is a non-destructive and reversible condition, however if not taken care may lead to periodontitis, abscess and ulcerative conditions of surrounding tissues and bones, tooth loss, chronic gingivitis.
Favorable dental health related behaviors are best established in pre-adolescent and adolescent age group and once established, offer promising resultsin improving one’s quality of life ahead. Schools provide an ideal setting to deliver oral health education and implementation of interventional programs in a cost effective and efficient manner.
One of the preclinical study namely “Antibacterial activity of homeopathic medications Lycopodium clavatum and Arsenicum album against periodontal bacteria†concludes that Arsenic album and Lycopodium clavatum tinctures are potent antimicrobials against five bacterial strains of the oral cavity. The study lacks in-vivo validation of the results. A review article on “Homoeopathy in Pediatric dentistry†shows that Homoeopathy can be used as a complementary therapy in dental ailments but no case studies were carried outfurther on it. Another review article “Complementary and alternative medicinesin oral health care†mentions use of Homoeopathic medicinesin various oro-facial disorders
The study has been proposed to validate the role of Homoeopathy in treating gingivitis successfully. It can offer not only a cost effective treatment but also avoid unnecessary use of antibiotics and mouthwashes which are often not preferred by dentist for children in respective age groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 10-16 years 2.Both genders
- •Children presenting with gingivitis I, II, III type/complaints of inflammation, bleeding or swelling of gums, bad breath, brown/yellow staining of teeth.
- •4.Children having no previous history of dental intervention (scaling)/taking any other oral medication/antibiotic past 01 month/mouth rinsing agents.
- •5.Children/parents/guardians willing to give written informed consent/assent to participate in the study.
排除标准
- •1.Diagnosed cases suffering from systemic illness such as diabetes, HIV infection, cardiovascular disease, hereditary gingival fibromatosis, acquired immunodeficiency syndrome, granulomatous disorders such as Crohn disease and Melkersson–Rosenthal syndrome, acute monocytic leukemia, tuberous sclerosis, fibrous/epithelial hyperplasia or benign neoplasm of periodontal ligament, Congenital Gum Synechiae, Congenital Epulis, anxiety, depression, emotional stress, sleep deprivation, Varicella herpes virus infection, Epstein.
- •Barr virus infection, coxsackie group A viruses infection, Wegeners Granulomatosis, acute ulcerative necrotizinggingivitis,lineargingivalerythema,a cuteherpeticgingiva-stomatitis ,candidiasis infection 2.Nutritionaldeficiencyinducedgingivitis(vitamin AandC),cancrumoris,druginduced gingivitis, gingivitis associated with abscess and attachment loss (periodontitis), traumatic gingivitis, muco-gingival deformities. 3.Children using medicated or herbal toothpaste 4.Children with history ofsmoking and/or Tobacco chewing.
结局指标
主要结局
Gingival index
时间窗: Baseline,3rd week,6th week,9th week,12th week
(GI)score
时间窗: Baseline,3rd week,6th week,9th week,12th week
次要结局
- Plaque index (PI)(Baseline,3rd week,6th week,9th week,12th week)
- To outline the frequently indicated homoeopathic medicines in(treatment of gingivitis.)
研究者
Dr Neha kalra
Central council of research in Homoeopathy