Impact of Vital Pulp Therapy in Acute Irreversible Pulpitis With Incipient Apical Periodontitis Cases Diagnosed by the Aid of Artificial Intelligence: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
This study evaluates postoperative pain and treatment outcomes following vital pulp therapy and root canal treatment in patients with symptomatic teeth. Participants will receive either vital pulp therapy or standard root canal treatment, and pain will be measured using standardized pain scores at different time intervals after treatment.
The primary outcome is postoperative pain intensity in the early healing period. Secondary outcomes include long-term clinical and radiographic success at 6 months and 1 year.
Radiographic outcomes will be assessed using artificial intelligence (AI)-assisted analysis to improve evaluation of healing and treatment success.
The study aims to compare pain progression and long-term outcomes between the two treatment approaches.
详细描述
This study is designed to evaluate postoperative pain and treatment outcomes following endodontic procedures, including both root canal treatment (RCT) and vital pulp therapy (VPT), in patients presenting with symptomatic pulpal conditions.
Participants will receive treatment according to clinical indication, either RCT or VPT. Postoperative pain will be assessed using standardized pain scoring systems at defined time intervals following treatment to evaluate short-term patient discomfort and recovery patterns.
The primary outcome measure is postoperative pain intensity following endodontic intervention during the early healing period.
Secondary outcomes include the long-term clinical and radiographic success of treated teeth, evaluated at 6 months and 1 year post-treatment.
Radiographic evaluation will be performed using standardized periapical radiographs, and outcomes will be assessed using artificial intelligence (AI)-assisted image analysis to support objective evaluation of periapical healing and treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No participants, care providers, investigators, or outcome assessors were blinded to the assigned intervention. Radiographic analysis was performed using standardized methods with AI-assisted evaluation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mandibular molars with with deep caries exposing the pulp and preoperative symptoms, such as spontaneous or referred pain.
- •Mandibular molars lacking noticeable radiolucency in the furcation or periapical areas. (Periapical Index scores of 1 and 2)
- •Patients aged 18-40 years with teeth diagnosed with acute irreversible pulpitis and symptomatic apical periodontitis.
- •Patients willing to provide written informed consent for participation in the study.
- •Restorable teeth and adequate periodontal support.
排除标准
- •Teeth with prior endodontic treatment or history of trauma.
- •Teeth with internal or external resorption, prominent radiolucency at the periapical regions or furcation. (Periapical Index score of 3, 4 and 5)
- •Teeth that are not responsive to vitality tests.
- •Pregnant or lactating women due to potential risks associated with radiographic exposure.
- •Patients with systemic diseases (e.g., uncontrolled diabetes, immunosuppression) that may affect healing.
- •Teeth with advanced periodontal disease (e.g., mobility grade II or III, furcation involvement).
- •Patients unable to attend follow-up appointments for up to one year.
研究组 & 干预措施
Vital Pulp Therapy
Participants receive vital pulp therapy for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up.
干预措施: Vital Pulp Therapy (Procedure)
Root Canal Treatment
Participants receive conventional root canal treatment for symptomatic teeth followed by postoperative pain assessment and radiographic follow-up.
干预措施: Root Canal Treatment (Procedure)
结局指标
主要结局
Pain Score
时间窗: 1 Week
Postoperative pain assessment using modified Visual Analogue Scale. Postoperative pain assessment after 24 hours and 1 week.
次要结局
- Clinical and AI- assisted Radiographic long term success rate of vital pulp therapy and Root Canal Treatment(1 Year)