Turmeric Gel as Alternative Non-Vital Pulpotomy Medicament in Primary Teeth-A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Antibacterial effect
研究概览
简要总结
The purpose of this randomized controlled clinical trial is to use Turmeric gel as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Turmeric gel compared with Formocresol, when used as non-vital Pulpotomy medicaments.
详细描述
It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Turmeric gel). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).
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
- Double (Participant, Outcomes Assessor)
盲法说明
patients and assessors involved in the study from randomization, allocation, bacteriological outcome, and data analysis will be blinded to which medicament group the patients belonged as all data will be coded.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperation of patients and consent of parents.
- •Patients with ASA classification I and II (mild to moderate systemic disease).
- •Non-traumatic extensively carious hence restorable primary molars.
- •No history of antibiotic use for 2 weeks.
- •Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/ redness/ swelling, and/or slight mobility-grade I.
排除标准
- •History of allergy to anesthetics and latex.
- •Radiographic evidence of pulpal floor opening into the furcation area.
- •More than half of the roots resorbed.
研究组 & 干预措施
Formocresol (Control-Gold standard-Group A)
Premade Formocresol (Tricresol & Formalin) was used composed of Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001_2000/ ISO13485/CE_MARK), (Universal Dental Pvt, Ltd).
干预措施: Formocresol (Drug)
Turmeric gel (Experimental-Group B)
Turmeric gel will be self-prepared at the Institute of Microbiology and Molecular Genetics, Punjab University, Lahore. 2kgs of Turmeric rhizomes were purchased from a local market in Lahore and verified by a taxonomist, Botany Department, Government College University, Lahore (voucher number: GC.Herb.Bot.3693). Approximately 170g powder along with 550ml distilled water will be taken in a Soxhlet extractor for 96 hours and then filtered repeatedly through Whatman No.1 filter paper. The obtained filtrate will then be mixed with 6% Sodium Carboxy-Methyl Cellulose (NaCMC) (Genevex Chem, Hyderabad, India) to form gel. Four Vitamin C grounded tablets (Wilson's Vitamin C, Wilson's Healthcare, Islamabad, Pakistan) and twelve Vitamin E capsules (Evion, Martin Dow pharmaceuticals, Ltd. Karachi, Pak) will then be added in 100g of gel as antioxidants.
干预措施: Turmeric Gel (Drug)
结局指标
主要结局
Antibacterial effect
时间窗: 1 week
Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)
次要结局
未报告次要终点
研究者
Dr. Mashal Mazhar
Dental Surgeon (Ex-Postgraduate trainee)
University of Health Sciences Lahore