Clinical, Radiographic, and Histologic Outcome of Sodium Hypoclorite as an Antibacterial Agent Prior to Calcium Hydroxide and Mineral Trioxide Aggregate Pulpotomies in Primary Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- Clinical success rate of pulpotomy
研究概览
简要总结
Aim: The aim of this study was to report the 24-Month radiographical and histological outcome on these previously reported calcium hydroxide (CH) and mineral trioxide aggregate (MTA) pulpotomies using of five percent sodium hypochlorite (NaOCl) as an antibacterial agent to clean the chamber prior to application of the pulpotomy agent.
Materials and Methods: 128 primary molars were randomly divided into two main groups according to pulpotomy material (CH/MTA) and into two sub-groups according to selected the antibacterial agent (NaOCl/physiologic saline) used in the pulpotomy procedure. After these procedures, teeth were followed radiographically for 24 months. Thirty-four successfully treated teeth whose successors roots had completed formation of at least two-thirds of their lengths were extracted for histological evaluation. Fisher's-exact test, Pearson's-chi-square test and MannWhitneyU test with Bonferroni correction were used for statistical analysis.
详细描述
The procedure and possible discomforts, risks, and benefits had been fully explained to the parents of the children, and informed consent forms were signed.
A total of 64 children (37 boys and 27 girls), between six to 10 years old (mean=8.2 years old) who had at least two mandibular primary molars with nearly equal carious involvement that required pulpotomy were included in the study. Following anesthesia and rubber dam isolation, the pulpotomy procedure was realized. After amputation of the coronal pulp tissue, pulpal hemorrhage was controlled using dry sterile cotton pellets under slight pressure for approximately 5 min. Four teeth were excluded from the study because of uncontrolled bleeding.
A total of 124 teeth were randomly distributed (by a coin toss) among groups representing different pulpotomy materials (CH or MTA) and cleansing agents (NaOCl or physiologic saline).
CH pulpotomy (n = 62 teeth): After hemorrhage control, two teeth in each child were randomly assigned by the toss of a coin to receive two cleansing agents, the experimental disinfecting agent 5% NaOCl (Wizard, Rehber Chemistry, Istanbul, Turkey) or the physiologic saline. CH control (n = 31 teeth): Pulp chamber was cleansed with physiologic saline prior the CH pulpotomy. CH NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey) paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany).
MTA pulpotomy (n = 62 teeth): As stated above, following the hemorrhage control, two cleansing agents were randomly applied to the cavity. MTA control (n= 31 teeth): Pulp chamber was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy. Then, canal orifices were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the teeth finally restored with SSCs.
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)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each child had at least two previously untreated lower 2nd primary mandibular molars with nearly equal carious involvement that required pulpotomies but showed positive response to vitality tests (electrical pulp test and cold stimulation)
- •The children were healthy and cooperative
- •Moderate response to chemical and thermal stimuli.
- •Teeth would be restorable with stainless steel crowns.
排除标准
- •Signs of irreversible pulpitis (such as spontaneous pain, prolonged pain response),
- •Presence of percussion or palpation,
- •Pathological mobility,
- •Infectious symptoms such as fistula or abscess,
- •Discoloration in the clinical examination,
- •Presence of radiolucency in the furcation or periodical regions thickening of the periodontal spaces
- •Internal or external root resorption.
结局指标
主要结局
Clinical success rate of pulpotomy
时间窗: Change of clinical success from Baseline at 24 month
Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.
Radiographic success rate of pulpotomy
时间窗: Change of radiographicsuccess from baseline at 24 month
For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. success was considered when internal/external root resorption and periapical/furcal radiolucency was not observed.
次要结局
- Histological success rate of indirect pulp treatment(up to 30 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation).])
研究者
Merve AKCAY
Assoc. Prof.
Izmir Katip Celebi University