Comparative Evaluation of Probiotic-Calcium Hydroxide Mix, Ozonated Coconut Oil-calcium hydroxide mix, and Conventional Calcium Hydroxide as a base in Indirect Pulp Capping of Primary Teeth: A Randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Clinical and radiographic success of indirect pulp capping assessed by absence of pain, swelling, tenderness, mobility, and periapical/furcal radiolucency; evidence of dentin bridge formation.
研究概览
简要总结
Dental caries is one of the most prevalent oral diseases affecting children and poses a challenge in managing deep carious lesions while maintaining pulp vitality. Indirect Pulp Therapy (IPT) aims to preserve the pulp by removing infected dentin and promoting reparative dentin formation using suitable capping materials.
Calcium hydroxide has been a traditional material for IPT due to its antibacterial and healing properties. However, newer agents such as probiotics and ozonated oils have shown potential benefits. Probiotics help in modulating oral microflora and enhancing tissue healing, while ozonated coconut oil possesses strong antimicrobial and anti-inflammatory actions that can accelerate repair and reduce infection.
This study is designed to compare the clinical and radiographic effectiveness of three materials:
- Probiotic-Calcium Hydroxide mix
- Ozonated Coconut Oil-Calcium Hydroxide mix
- Conventional Calcium Hydroxide
A randomized controlled trial will be conducted on 105 primary molars (5–9 years age group) divided equally into three groups. Clinical and radiographic evaluations will be performed at 3, 6, 9, and 12 months, with CBCT assessment at 12 months to evaluate dentin bridge formation.
The study aims to identify a more effective material for indirect pulp capping that enhances antibacterial activity, promotes dentinogenesis, reduces inflammation, and maintains pulp vitality in primary teeth.
The results may provide valuable insights into improving minimally invasive vital pulp therapy in pediatric dentistry using biologically active materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children who are willing to participate in the study and informed consent was obtained from parents.
- •CLINICAL CRITERIA Systemically healthy children of age 5-9 yrs with primary molars indicated for indirect pulp capping.
- •Teeth with deep caries but vital pulp .
- •RADIOLOGICAL CRITERIA: No history of swelling sinus tract or abscess.
- •Intact periodontal ligament space.
- •No evidence of internal or external root resorption.
- •No periapical or furcal radiolucency.
排除标准
- •Children who are not willing to participate in the study.
- •Teeth with spontaneous pain or signs of irreversible pulpitis.
- •Presence of swelling sinus tract or abscess.
- •Teeth with abnormal mobility unrelated to physiological exfoliation.
- •Systemic conditions affecting wound healing or immunity.
- •Presence of periapical or furcal radiolucency.
- •Internal or external resorption detected.
- •Presence of calcific degeneration or pulp obliteration.
结局指标
主要结局
Clinical and radiographic success of indirect pulp capping assessed by absence of pain, swelling, tenderness, mobility, and periapical/furcal radiolucency; evidence of dentin bridge formation.
时间窗: At follow-up visits — 3, 6, 9, and 12 months (CBCT at 12-month follow-up).
次要结局
- Evaluation of dentin bridge formation by assessing pulp vitality using clinical and CBCT assessment.(At follow-up visits — 3, 6, 9, and 12 months (CBCT at 12-month follow-up).)
研究者
G YUKTA PRAGNYANI
MNR DENTAL COLLEGE AND HOSPITAL