Efficacy of Individualized Homeopathic Medicines in Managing Pain of Dental Caries in Teenagers and Adults: A Double-blind, Randomized, Placebo-controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The Pain Visual Analogue Scale (VAS)
研究概览
简要总结
Dental caries is a chronic, multifactorial disease driven by biofilm and acid production from bacteria like Streptococcus mutans. These bacteria convert dietary sugars into acids, mainly lactic acid, which lower the pH and lead to the breakdown of enamel and dentin by dissolving hydroxyapatite. When demineralization outweighs the natural protective effects of saliva and remineralization, carious lesions form and progress. Early signs include white spots indicating subsurface enamel demineralization. Persistent acid exposure roughens enamel and can eventually cause cavitations. Lesions may remain within enamel for 3–4 years before becoming radiographically visible. Dental pain is defined as discomfort arising from tooth structures or their supporting tissues. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 192 teenagers and adults who are suffering from pain of dental caries at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by the Pain VAS Score [primary outcomes]; the Oral Health Impact Profile – 14 item version (OHIP-14) will be employed to measure the effect of oral health conditions on quality of life. [Secondary outcome] Second, change in caries status using ICDAS II (International Caries Detection and Assessment System) [secondary outcome]. Comparative analysis will be carried out to detect group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 12–65 years
- •Participants of either sex or transgender.
- •Toothache from dental caries.
排除标准
- •Not providing with written informed assent and or consent of participation.
- •Other orofacial pain conditions of nonodontogenic origin.
- •Patients with Pain VAS score more or equal to 7.5 (75mm)
- •Recent steroid or antibiotic therapy for dental pain, gingivitis, periodontitis.
- •Spontaneous bleeding gum associated with the systemic disorder.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting the quality of life or any organ failure.
- •Pregnant and puerperal women, lactating mothers.
- •Vulnerable population that is unconscious, ambulatory, too sick for consultation.
- •Differently abled, terminally or critically ill patients, mentally incompetent people.
- •Self reported immune compromised states.
- •Already undergoing homeopathic treatment for chronic disease within last 2 weeks.
- •Tobacco chewing and or smoking, alcoholism and or any form(s) of substance abuse and/or dependence (TAPS tool)
- •Simultaneous participants in any other clinical trial.
结局指标
主要结局
The Pain Visual Analogue Scale (VAS)
时间窗: At Baseline, Day 2, Day 6, Day 14
次要结局
- Oral health-related quality of life (OHIP-14 scores)(At Baseline, Day 2, Day 6, Day 14)
- International Caries Detection and Assessment System (ICDAS II) criteria(At Baseline, Day 2, Day 6, Day 14)
研究者
Md Sayed
D N De Homoeopathic Medical College and Hospital
