Investigating the impact of Homeopathic therapy on Clinical Metabolic Control and Systemic Inflammatory Markers in Patients of Stage III and Stage IV Periodontitis with Diabetes: A Randomized Multi- Arm Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Bleeding on Probing (BOP)
研究概览
简要总结
Periodontitis and Diabetes mellitus are prevalent chronic conditions worldwide. Periodontitis is an inflammatory disease associated with dysbiotic plaque biofilms, leading to the progressive deterioration of the tooth-supporting structures. Homeopathy is believed to restore the body’s vital energy balance, promoting self-healing. It is a therapeutic system based on the principle of similarity and uses medicines from all the kingdoms of nature (mineral, vegetable, and animal). Therefore, this study aims to employ a well-designed clinical trial to evaluate the effectiveness of homeopathy as an adjunct to non-surgical periodontal therapy (NSPT) in diabetic patients with stage III and severe periodontitis. This double-blinded Randomized Four Arm Clinical Trial will be conducted at the Department of Periodontology, SRM Kattankulathur Dental College and Hospital. A total of 400 participants aged 30 to 70 years, were diagnosed with Stage III & IV Periodontitis, having type 2 diabetes HbA1c with 7.5-8%. There is no modification in diabetic medication in the last three months before or during the study will be included. All participants will receive ant-diabetic medicines as standard care and subsequently, the participants will be randomized into four groups a) Group 1 (NSPT +Placebo) b) Group 2 (NSPT + IH) c) Group 3 (NSPT + IH + Placebo mouthwash)d) Group 4 (NSPT + IH+ Calendula mouthwash). The study’s primary objective is to evaluate the effectiveness of individualized homeopathic remedies (IH) compared to placebo in reducing the severity of periodontitis in patients with type 2 diabetes mellitus (T2DM) diagnosed with Stage III and IV disease. The secondary objective is evaluating the homeopathic medicine-mediated mitigation of serum biomarkers for glycemic parameters, such as Fasting blood glucose levels, HbA1c, and other clinical values, between the intervention and control groups , to investigate the impact of homeopathic medicine on the levels of specific inflammatory biomarkers (IL-1beta, IL-6, TNF-alpha, IL-17, and MMP-8) between the groups at defined time points in saliva samples, to evaluate the influence of homeopathic medicine on the levels of PINK1 /PARKIN Proteins between the intervention and control groups in serum samples and to assess the Oral Health-Related Quality of Life (OHRQoL), using Oral Health Impact Profile (OHIP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged 30 to 70 years, diagnosed with Stage III & IV Periodontitis
- •Participants must have type 2 diabetes HbA1c with 7.5-8%
- •No modification in diabetic medication in the last three months before or during the study.
排除标准
- •Patients affected with any systemic conditions known to exert effects of any kind in the study or on the assessed parameters.
- •Patients diagnosed with type 1 diabetes
- •Pregnant and lactating females.
- •5 Any form of periodontal therapy in the previous 6 months.
- •Use of any antimicrobials in the last three months.
- •Any other infections (e.g., Common cold, influenza, ENT infections, etc.) may affect any change in the considered study parameters.
- •Patients undergoing or have undergone radiation therapy in the recent past.
- •Long-standing infections of any kind and patients on chemotherapy
- •Uncontrolled hypertension.
结局指标
主要结局
Bleeding on Probing (BOP)
时间窗: baseline, month1, month 3 & month6
Probing Pocket Depth (PPD)
时间窗: baseline, month1, month 3 & month6
Clinical Attachment Level (CAL)
时间窗: baseline, month1, month 3 & month6
次要结局
- Fasting blood glucose levels and HbA1c(Baseline, month1, month3, month6)
- Analysis of specific inflammatory biomarkers (IL-1Beta, IL-6, TNF-alpha, IL-17, and MMP-8) in saliva samples(Baseline,month1, month 3 & month6 ,)
- Measurement of PINK1/PARKIN proteins in serum samples to explore their levels and any alterations between intervention and control groups(Baseline, month1, month 3 & month6)
- To assess the Oral Health-Related Quality of Life (OHRQoL), using Oral Health Impact Profile (OHIP).(Baseline, month1, month 3 & month6)
研究者
Dr Vivek N
SRM Kattankulathur Dental College and Hospital , SRM IST, Kattankulathur, Tamil Nadu, India