BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars: A 12-Month Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
研究概览
简要总结
The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in children vital primary molars.
A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at 3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests. The level of significance was set at P < 0.05.
详细描述
Methods This study was written according to the Consolidated Standards of Reporting Trials (CONSORT) statement.
Study design A double-blinded, split-mouth, randomized, controlled clinical study was done. Patients This study was carried out on healthy children aged 4- to 8-year-old. The children were selected from the Pediatric Dentistry Clinics, Faculty of Dentistry, King Abdulaziz University (KAU), Jeddah. Each patient had at least 2 matched bilateral carious primary molars requiring pulpotomy. Each parent signed an informed consent for the child's participation in the study. No children were excluded based on gender, race, social or economic status.
Teeth were selected based upon clinical and radiographic criteria. Teeth were unselected if any of the inclusion criteria were not met.
Preoperative periapical radiographs of the molars considered for treatment were taken using the XCP extension cone paralleling technique.
Sample size and power determination Sample size calculation for binary outcome equivalence trials was calculated using sample size calculators of a sealed envelope, randomization and online databases for clinical trials at https://www.sealedenvelope.com/power/binary-equivalence/ Thus, if there is truly no difference between the standard and experimental materials, then 102 teeth (51 for each study material) are required to be 95% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 10%. It is usually prudent to plan to include more than the minimum number of teeth in a study to compensate for loss during follow-up or other causes of attrition. The percentage of teeth that could be lost to follow up at all stages was set at 10% thereby forcing an increase of 5 pairs to the calculated sample size. Thus, the final sample size for this study was calculated to be 112 teeth.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BiodentineTM pulpotomy group
A Bioactive Dentine Substitute (BiodentineTM, Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface.
干预措施: BiodentineTM (Other)
BiodentineTM pulpotomy group
A Bioactive Dentine Substitute (BiodentineTM, Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface.
干预措施: Formocresol (Drug)
Formocresol pulpotomy group
A sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing.
干预措施: BiodentineTM (Other)
Formocresol pulpotomy group
A sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing.
干预措施: Formocresol (Drug)
结局指标
主要结局
Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
时间窗: After 6 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment
时间窗: After 6 months
Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment
时间窗: After 3 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
时间窗: After12 months
Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.
Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment
时间窗: After 12 months
Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.
次要结局
未报告次要终点
研究者
Najlaa Alamoudi
Professor in Pediatric Dentistry Department, Medical Director, KAU-DH Program Director, Post Grad Studies for Master and PhD programs Program Director,of Saudi Commission for Health Specialities, Faculty of Dentistry- King Abdulaziz University
King Abdulaziz University