Comparative evaluation of the clinical and radiographic success rates of Triple antibiotic paste, modified triple antibiotic paste and Metapex in the treatment of infected primary molars with poor prognosis: A Randomized clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Resolution of pain, tenderness, mobility, clinically
研究概览
简要总结
This randomized clinical study aims to evaluate and compare the clinical and radiographic success of three intracanal medicaments—Triple Antibiotic Paste (TAP), Modified Triple Antibiotic Paste (MTAP), and Metapex—in treating infected primary molars with poor prognosis in children.
The importance lies in preserving primary teeth until natural exfoliation to prevent functional and developmental issues caused by premature tooth loss. The Lesion Sterilization and Tissue Repair (LSTR) technique, using antibiotic pastes, offers a less invasive alternative to conventional pulpectomy.
Key Points:
- Triple antibiotic paste (TAP) includes ciprofloxacin, metronidazole, and minocycline.
- Modified TAP substitutes minocycline with doxycycline or adds cefixime.
- Metapex is a calcium hydroxide and iodoform paste commonly used in pulpectomy.
Objectives:
- Evaluate individual and comparative success of TAP, MTAP, and Metapex in treating nonvital primary molars.
Methodology:
- 75 children divided into 3 groups (n=25 each).
- Group I: TAP
- Group II: MTAP
- Group III: Metapex
- Clinical and radiographic evaluation at 1, 3, 6, 9, and 12 months.
- Data analyzed using SPSS software.
Clinical Procedures:
- LSTR involved medicament placement on pulpal floor and sealing with GIC.
- Pulpectomy involved chemo-mechanical preparation and obturation with Metapex followed by stainless steel crown restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary molars selected in this study will be based on clinical and radiographic screening.
- •Pulpally involved primary teeth (nonvital)
- •Gingival abscess, presence of fistula
- •Failed pulpotomy
- •Teeth with radiographic evidence of internal or external root resorption
- •Furcation or periapical radiolucency.
- •Excessive root resorption involving more than half of the root.
排除标准
- •Teeth with pulpal floor perforation
- •Systemically compromised and patients with history of drug allergy.
结局指标
主要结局
Resolution of pain, tenderness, mobility, clinically
时间窗: 1 week, 1 month, 3 months, 6months, 9 months, 12 months
次要结局
- Radiographic resolution of radiolucency.(3 months, 6months, 9 months, 12 months)
研究者
Dr Yash Jaju
JMFs ACPM Dental college and Hospital, Dhule