Clinical and Radiographic Outcomes of Pulpotomy of Primary Molars Using Totalfill® Bioceramic Root Repair Material -Fast Set Putty, and ProRoot White MTA®. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control.
详细描述
When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover the rest with a suitable material is required. The Purpose of this study is to check the success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents: (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use of the materials has no side effect or complications as it is a routine dental procedure.
The participants are healthy children aged between 3 and 9 years old, and the study is taking place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in duration of 4 years, which include 20 months for participants recruitment.
After placing the material, the tooth is restored with stainless steel crowns, and the participant was asked for follow up to check the tooth and to take dental x-ray every 6 months.
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
The included teeth were assigned randomly into two groups (Totalfill or MTA) using randomized sequences generated by the computer using Random Integer Generator (RANDOM.ORG, Randomness and Integrity Services Ltd.). The allocation ratio to the groups was set to be equal.
To ensure double blinding at both patients and evaluators level during treatment, the type of material was concealed from the patient, and the patient had no information which material was used. In addition, the type of material was not mentioned in the patient file. Instead, it was replaced by a 4 digit code. The operators were also blinded for the type of material during the whole procedure starting from tooth preparation till the hemostasis was achieved and then were only informed at the time of material placement.
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient inclusion criteria
- •ASA 1 patient, Patient is a completely healthy & fit. No allergy or medical conditions.
- •Patient is indicated for treatment under General Anesthesia: young age, uncooperative and extensive treatment plan.
- •Parent agreed to participate in the study, and signed the written consent.
- •Patient attended the out-patients pediatric dental clinic in UZ Gent.
- •Tooth inclusion criteria 2.
- •Clinical inclusion criteria:
- •Vital primary molars (first or second) with deep caries cavity with pulpal exposure.
- •Only mandibular primary molar were included
- •No spontaneous pain
- •No history of swelling
- •No sinus tract/ fistula
- •Absent of tenderness in percussion
- •No pathological mobility
- •Restorable tooth (stainless steel crown can be placed)
- •Hemostasis can be achieved with a dry cotton pellet after removal of Coronal pulp.
- •Radiographical inclusion criteria:
- •At least 2/3rd of root is present
- •Absence of internal or external root resorption
- •Absence of pathologic root resorption
- •Absence of periapical or furcation radiolucency
排除标准
- •If one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.
研究组 & 干预措施
Totalfill
Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy
干预措施: Totalfill (Drug)
MTA
ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy
干预措施: MTA (Drug)
结局指标
主要结局
Clinical evaluation
时间窗: 12 months follow-up
Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
Radiographic evaluation
时间窗: 12 months follow-up
Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.
次要结局
- Time needed to place the material(Immediately after each intervention for a maximum of the intervention)