Evaluation of Post-operative Pain After Vital Pulpotomy in Molars With Symptomatic Pulpitis: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Postoperative Pain Assesment
研究概览
简要总结
The goal of this clinical trial is to investigate post-operative pain (PEP) in teeth with symptomatic pulpitis following Vital Pulpotomy Treatments (VPT) with Calcium Silicate Cement (CSC). The main questions it aims to answer are:
- Is the post-operative pain one week after VPT significantly lower than pre-operative pain in permanent molars with symptomatic pulpitis?
- How does post-operative pain in these teeth correlate with patient-related factors, such as age, gender, and painkiller intake?
Participants will:
- Undergo Vital Pulpotomy Treatment with Calcium Silicate Cement (MTA)
- Provide pain level assessments before VPT, immediately post-treatment, and at 24, 72 hours, and 1 week after treatment.
If there is a comparison group:
Researchers will compare the post-operative pain levels in teeth with symptomatic pulpitis undergoing VPT to assess its effectiveness in reducing pain compared to a control group not undergoing the treatment.
详细描述
Informed Consent:
Volunteers or parents will receive detailed information about protocols, risks, and benefits. Informed consent was obtained in writing after providing subject information, and participants could withdraw voluntarily at any time.
Sample Size Calculation:
Sample size calculation, utilizing G. Power-3.1.9.2, aimed at relationship analyses with a 95% confidence level, α=0.05, effect size of 0.30, and theoretical power of 0.80, resulting in a minimum sample size of 108.
Treatment Procedure:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 7 and 70 years
- •The teeth with diagnosis of irreversible symptomatic pulpitis
- •Permanent first and second molars with vital pulp
- •PAI ≤ 2 with vital pulp. (Ørstavik D, Kerekes K, & Eriksen HM (1986) The periapical index: A scoring system for radiographic assessment of apical periodontitis Dent Traumatol 2(1) 20-34, https://doi.org/10.1111/j.1600-9657.1986.tb00119.x.)
排除标准
- •Clinical or radiographic signs of a necrotic pulp
- •The presence of a sinus, buccal tenderness, pathological mobility or evidence of pathology on a periapical radiograph
- •Teeth with horizontal or vertical root fractures
- •Swelling, acute endodontic, or periodontal abscess
- •Insufficient tooth tissue for a restoration, teeth requiring a post
- •Unable to give informed consent
- •Contraindicated systemic disease
- •Allergies the local anesthesia
- •Antibiotics, biphosphonates, and corticosteroid intake during the 7 days before treatment.
- •Pregnancy or breastfeeding.
- •Patients who needed endodontic treatment on several teeth to avoid a potentially confused pain referral.
结局指标
主要结局
Postoperative Pain Assesment
时间窗: 1) on treatment day, before starting the treatment; 2)24 hours later; 3)72 hours later and 4) 1 week later
Pain scores before and after treatment will be assessed using a modified Wong-Baker pain rating scale. The patients and parents will be given with comprehensive information and instructed to indicate their level of pain using a pain rating scale (0 = no pain, 1 = slight pain, 2 = moderate pain, 3 = severe pain) before treatment, at 24 hours, and 72 hours after the procedure. Additionally, they will be asked about the use of painkillers.
次要结局
未报告次要终点
研究者
Hasibe Elif Kuru
Assistant Professor
Uşak University