Outcome of Pulpotomy in MIH Affected Teeth With Carious Pulp Exposure: A Prospective Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Success of pulpotomy
研究概览
简要总结
The first permanent molars in children can sometimes develop a condition called molar-incisor hypomineralization (MIH), which affects the strength and quality of the tooth structure. These teeth are more prone to breakdown and tooth decay, which may lead to inflammation of the dental pulp (the living tissue inside the tooth).
This study aims to evaluate the effectiveness of vital pulp therapy, a treatment designed to preserve the health of the pulp and maintain the tooth's function. The goal is to save the pulp tissue and reduce the need for more complex treatments such as root canal therapy.
详细描述
Molar-incisor hypomineralization (MIH) is a developmental enamel defect affecting permanent first molars and incisors. Affected molars are more vulnerable to post-eruptive enamel breakdown, dental caries progression, and subsequent pulpal inflammation. When caries progresses to involve the pulp, preserving pulp vitality through vital pulp therapy (VPT) may provide an alternative to root canal treatment, particularly in young patients.
Although partial and full pulpotomy have shown favorable outcomes in young permanent teeth with deep caries and pulp exposure, limited evidence is available regarding their effectiveness in teeth affected by MIH. MIH-affected teeth may have altered pulpal characteristics, including increased vascularity, inflammatory response, and sensitivity, which may influence the response to vital pulp therapy.
This prospective clinical study aims to evaluate the clinical and radiographic outcomes of a stepwise pulpotomy approach in young permanent first molars affected by MIH with deep caries and pulp exposure. Eligible teeth will initially receive partial pulpotomy. If adequate hemostasis cannot be achieved following partial pulpotomy, treatment will be converted to full pulpotomy. A calcium silicate-based material will be used for pulp capping, followed by definitive restoration.
Clinical and patient-reported outcomes will be assessed, including postoperative pain, the need for emergency intervention, and signs or symptoms of treatment failure. Radiographic evaluation will be performed at 6 and 12 months using periapical radiographs, with additional imaging when indicated, to assess the presence of periapical or furcal pathology, root changes, and overall treatment success.
The study will also investigate potential factors associated with treatment outcomes, including patient and tooth characteristics, MIH severity, pulpotomy type performed (partial or full pulpotomy), and pulpal inflammatory markers such as matrix metalloproteinase-9 (MMP-9). The findings will contribute to understanding the effectiveness and predictability of vital pulp therapy for MIH-affected permanent molars with carious pulp exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• The patient age <14 years old
- •Non -contributory medical history
- •Molar tooth affected with MIH as per EAPD diagnostic criteria (17).
- •Deep caries extending>= 2/3 of dentine or exposing the pulp on the radiograph
- •The tooth should give positive response to cold sensibility testing
- •Clinical diagnosis of reversible/irreversible pulpitis based on the symptoms and results of cold testing.
- •The tooth is restorable, probing pocket depth and mobility are within normal limits
- •No signs of pulpal necrosis including sinus tract or swelling
排除标准
- •• Medically compromised patient.
- •Non-restorable tooth.
- •Signs of pulpal necrosis including sinus tract or swelling.
- •Uncooperative children who could not be treated under local anesthesia.
- •No enough bleeding after the pulpotomy procedure.
- •Inability to achieve hemostasis within 8 min after the pulpotomy.
研究组 & 干预措施
MIH-Affected Permanent Molars Receiving Stepwise Pulpotomy Treatment
MIH affected molars will receive a stepwise vital pulp therapy approach. Partial pulpotomy will be performed initially, and if adequate hemostasis cannot be achieved, the procedure will be converted to full pulpotomy. A calcium silicate-based pulp capping material and definitive restoration will be placed following the pulpotomy procedure. Participants will be followed clinically and radiographically for treatment outcomes.
干预措施: Step wise pulpotomy (Procedure)
结局指标
主要结局
Success of pulpotomy
时间窗: 6 and 12 months after treatment
Clinical and radiographic success will be assessed based on the presence or absence of signs and symptoms of treatment failure at follow-up visits. Clinical success will be defined as the absence of spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, abnormal mobility, or other clinical signs of pulpal or periapical disease. For teeth undergoing partial pulpotomy, continued positive response to pulp sensibility testing will also be considered a criterion for clinical success. Radiographic success will be defined as the absence of new pathological findings, including periapical or furcal radiolucency, root resorption, or other radiographic evidence of treatment failure on follow-up imaging.
次要结局
- Postoperative pain after pulpotomy(One week after pulpotomy)
研究者
Nessrin Taha
Professsor
Jordan University of Science and Technology