Comparative Evaluation of Clinical and Radiographic Outcomes of Mustard Gel (Brassica Nigra) and Mineral Trioxide Aggregate (MTA) as Pulpotomy Agents in Deciduous Molars- A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Clinical and Radiographic success rate of Pulpotomy
研究概览
简要总结
The aim of this clinical trial is to compare two materials to treat baby molars with deep cavities. When the cavity is very deep and reaches the nerve of a baby tooth, dentist perform a treatment called "Pulpotomy". This means removing the damaged part of the nerve and placing medicament on healthy part to help tooth heal and stay pain-free until it falls out naturally. The standard medicine used today is Mineral Trioxide Aggregate (MTA) for treating baby molars that have deep cavities. It works well but is expensive and can darken the tooth. The study is testing a new medicine called Mustard Gel , made from black mustard seeds and may help heal the tooth. Mustard has natural healing and germ-fighting properties.This trial will help to compare Mustard Gel with MTA to see if the agent works to treat pulpitis.
Children aged 6-8 years who need a pulpotomy procedure on a baby molar will be selected. During this procedure, infected part of the pulp tissue will be removed and medicament will be placed over the remaining healthy pulp.
Selected participants will be put into one of the two groups by chance:
- Mustard Gel Group : tooth will be treated with mustard gel after nerve removal
- MTA Group : tooth will be treated with MTA, the current standard material. All the teeth will be sealed with a permanent filling material.Participants will be treated with both drugs and monitored after about 1 week, 1 month and 3 months to see if the tooth is pain-free and looks healthy on X-ray. The study will help check if Mustard gel is safe and if it causes any side effects.
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
- Single (Participant)
盲法说明
double blinded where participants and data analyst will be masked
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •healthy co-operative children 6-8 years old
- •primary molars with deep cavities and iatrogenic pulp exposure
- •clinically with no sign of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility
- •radiographically with absence of periapical radiolucency, internal/external root resorption, furcal radiolucency
- •hemorrhage at the site of amputation controlled with 5 minutes
- •tooth should be vital with healthy peridontium
- •tooth should be restoreable
排除标准
- •teeth without permanent successor
- •teeth with history of irreversible pulpitis
- •post amputation unsuccessful hemorrhage control even after 5 minutes
- •radiographic evidence of internal/external root resorption, furcal/periapical pathology
- •patients with drug allergies or systemic diseases
- •clinical signs of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility
研究组 & 干预措施
Arm A : Mustard Gel Pulpotomy
Primary molars will undergo pulpotomy followed by application of Mustard Gel in as pulpotomy medicament. After the removal of coronal pulp tissue and hemostasis the mustard gel will be applied directly over the radicular pulp stumps under aseptic conditions followed by the placement of suitable base and permanent filling material to seal tooth. Clinical and radiographic follow up will be done at 1 week, 1 month, and 3 months.
干预措施: Intervention 1: Mustard Gel (Drug)
Arm B: Mineral Trioxide Aggregate Pulpotomy
MTA will be used as pulpotomy agent in decidoud molars following standard clinical procedure after coronal pulp amputation. The treated tooth will be restored with appropriate base and final restoration. Clinical and radiographic follow up will be done at 1 week, 1 month and 3 months.
干预措施: Intervention 2 : Mineral Trioxide Aggregate (MTA) (Drug)
结局指标
主要结局
Clinical and Radiographic success rate of Pulpotomy
时间窗: At 1 week, 1 month, 3 months post treatment.
The proportion of the teeth treated with pulpotomy that show clinical and radiographic success. Clinical success rate is defined as absence of pain, swelling, abscess or pathological mobility. Radiographic success is defined as absence of internal/external root resorption, furcal/periapical radiolucency or widened PDL space. assessment will be done using clinical examination and periapical radiographs.
次要结局
未报告次要终点
研究者
Dr Nida Farooq
Post Graduate Resident, Department of Operative Dentistry
Postgraduate Medical Institute, Lahore