Twelve-Month Prospective Evaluation of Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of participants with clinical success after pulpotomy in primary molars
研究概览
简要总结
This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Children aged 4 to 7 who need this procedure will receive one of four materials: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, or Sodium Hypochlorite gel. The treated teeth will be checked at 6 and 12 months to evaluate the success of each material. The goal is to identify the most effective and reliable material for pulpotomy in primary molars.
详细描述
Vital pulpotomy is a conservative and widely used treatment to maintain the function of primary molars affected by deep carious lesions. The choice of pulpotomy medicament plays a significant role in the long-term success of the procedure.
This randomized clinical trial is designed to compare the clinical and radiographic success rates of four pulpotomy agents: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate (FS), and Sodium Hypochlorite gel (NaOCl gel).
A total of 88 mandibular second primary molars in children aged 4 to 7 years will be included. After coronal pulp removal, one of the four materials will be applied to the pulp tissue. All treated teeth will be restored with stainless steel crowns. Follow-up evaluations will be performed at 6 and 12 months to assess the clinical and radiographic success of each material.
The findings from this study are expected to help determine the most effective and reliable pulpotomy material for use in pediatric dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to the treatment allocation to reduce assessment bias. Participants, care providers, and investigators are aware of the assigned treatments.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 4 and 7 years
- •At least one primary molar indicated for pulpotomy
- •No spontaneous pain or systemic infection
- •Cooperative behavior according to the Frankl Behavior Rating Scale (scores 3 or 4)
- •Signed informed consent from parents or legal guardians
排除标准
- •Medically compromised children or presence of systemic diseases (e.g., bleeding disorders, immunodeficiency)
- •Uncooperative behavior (Frankl rating 1 or 2)
- •Primary teeth with signs of pulpal necrosis, abscess, sinus tract, or non-restorable crown
- •History of allergy to any materials used in the study
研究组 & 干预措施
MTA Group
Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament.
干预措施: Mineral Trioxide Aggregate (MTA) (Drug)
Biodentine Group
Primary molars treated with Biodentine as the pulpotomy medicament.
干预措施: Biodentine (Drug)
Ferric Sulfate Group
Primary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament.
干预措施: Ferric Sulfate (Drug)
Sodium Hypochlorite Gel Group
Primary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament.
干预措施: Sodium hypochlorite gel application (Drug)
结局指标
主要结局
Number of participants with clinical success after pulpotomy in primary molars
时间窗: 12 months after pulpotomy
Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination.
次要结局
- Number of participants with radiographic success after pulpotomy in primary molars(12 months after pulpotomy)
研究者
Sacide Duman
Assoc. Prof. Dr.
Inonu University