Clinical and Radiographic Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex Pulpectomy in Non-vital Primary Molars.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- fissure-exact test
研究概览
简要总结
The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.
详细描述
This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:
- •badly decayed with signs of irreversible pulpitis,
- •necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,
- •All the teeth included, had physiological root resorption of less than one third of the root.
- •Exclusion Criteria
- •Teeth showing radiographic evidence of excessive internal or external root resorption,
- •perforated pulpal floor,
- •excessive bone loss in furcation area involving the underlying tooth germ,
- •non- restorable teeth were excluded from the study.
排除标准
- 未提供
研究组 & 干预措施
TAP group
干预措施: triple antibiotic paste (TAP) (Drug)
Vitapex group
干预措施: Vitapex (calcium hydroxide/iodoform paste) (Drug)
结局指标
主要结局
fissure-exact test
时间窗: up to 12 months
The success rate of case and control groups, at 6 and 12 months follow-ups, are compared by Fissure-Exact Test.
次要结局
未报告次要终点
研究者
Heba sabbagh
assistant professor
King Abdulaziz University