Evaluation of Postoperative Pain After Pulpotomy Using Calcium Silicate Cements in Permanent Molars With and Without Laser Biomodulation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
This study evaluates treatment options for children and young adults with severe toothache in a permanent molar caused by symptomatic irreversible pulpitis. Conventional treatment involves non-surgical root canal treatment, which removes the entire dental pulp. An alternative approach, vital pulp therapy (full pulpotomy), removes only the inflamed coronal pulp while preserving the healthy radicular pulp, followed by placement of a bioactive calcium silicate cement.
The study compares two pulpotomy protocols. One group will receive EndoCem as the pulpal dressing material, while the other group will receive Er,Cr:YSGG laser biomodulation of the remaining pulp tissue before placement of EndoCem. Laser biomodulation is intended to reduce inflammation and promote tissue healing.
Participants will be randomly assigned to one of the two treatment groups. The primary outcome is postoperative pain, which will be assessed using a Visual Analogue Scale (VAS) at predetermined time points after treatment. The study aims to determine whether adjunctive laser biomodulation reduces postoperative pain compared with EndoCem alone and improves patient comfort following full pulpotomy.
详细描述
This study is a prospective, triple-blind, randomized controlled trial with two parallel arms and a 1:1 allocation ratio. The trial investigates the efficacy of adjunctive Er,Cr:YSGG laser biomodulation in reducing postoperative pain following full pulpotomy in permanent molars diagnosed with symptomatic irreversible pulpitis.
Non-surgical root canal treatment has traditionally been the standard treatment for symptomatic irreversible pulpitis because it involves complete removal of the dental pulp. However, advances in bioactive calcium silicate materials have established vital pulp therapy, particularly full pulpotomy, as a biologically conservative treatment option for mature permanent teeth. Full pulpotomy preserves the vitality of the radicular pulp while maintaining the tooth's biological defense mechanisms and proprioception and can be completed with less procedural complexity than conventional root canal treatment.
The study material is EndoCem, a premixed calcium silicate cement with favorable biocompatibility, bioactivity, and sealing ability. The experimental intervention consists of applying Er,Cr:YSGG laser energy to the exposed radicular pulp tissue after hemostasis and before placement of EndoCem. The laser will be operated in a non-ablative biomodulation mode. The proposed biological effects include stimulation of pulpal cells, enhancement of local microcirculation, modulation of inflammatory responses, and promotion of tissue healing, which may reduce postoperative pain.
Eligible participants presenting to the outpatient clinic will be screened according to the study eligibility criteria. Following informed consent, participants will be randomly assigned to one of two groups:
Group 1 (Control): Full pulpotomy followed by placement of EndoCem cement and definitive restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The operating clinician performing the pulpotomy procedure cannot be blinded due to the nature of the laser intervention. However, to maintain blinding, this clinician will not be involved in postoperative assessments. The participant, the independent assessor who collects the pain scores (Outcomes Assessor), and the statistician analyzing the final data will all be unaware of the group assignments.
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 9 and 14 years of age
- •Presence of a two-rooted permanent mandibular molar
- •Clinical diagnosis of symptomatic irreversible pulpitis in the study tooth
- •Study tooth considered restorable with a definitive restoration
- •Study tooth is periodontally healthy, with no mobility and no tenderness to percussion or palpation
- •Participant and/or parent/legal guardian is able and willing to provide written informed consent
排除标准
- •Teeth with immature root apices
- •Teeth that are non-restorable because of extensive caries or structural damage
- •Inability to achieve hemostasis within 10 minutes after coronal pulp removal
- •Participants with significant systemic medical conditions that may affect dental treatment or healing
- •Teeth diagnosed with pulpal necrosis
- •Inability or unwillingness of the participant and/or parent/legal guardian to provide informed consent
- •Individuals belonging to vulnerable populations, as defined by the institutional ethics committee
研究组 & 干预措施
EndoCem Pulpotomy
Participants in this arm will receive a full pulpotomy procedure for the treatment of symptomatic irreversible pulpitis. Following coronal pulp removal and hemostasis, the vital radicular pulp tissue will be covered with the calcium silicate cement EndoCem (ZTM Medicare, Pre-mixed MTA Putty), applied according to the manufacturer's instructions. The tooth will then receive a final restoration. This arm serves as the active comparator, evaluating the standard vital pulp therapy protocol using a modern bioceramic material.
干预措施: Calcium Silicate Cement (Device)
EndoCem + Laser Pulpotomy
Participants in this arm will receive an identical full pulpotomy procedure. However, prior to the placement of the EndoCem cement, the exposed radicular pulp stumps will undergo Er,Cr:YSGG laser biomodulation. The laser will be applied in a non-ablative, biostimulatory mode using specific parameters (e.g., 1.0 W, 20 Hz, 50 mJ, 60% water, 70% air) for a predetermined duration to achieve the biomodulation effect. Following laser application, EndoCem cement is placed and the tooth is restored. This is the experimental arm investigating the adjunctive effect of laser therapy.
干预措施: Calcium Silicate Cement (Device)
EndoCem + Laser Pulpotomy
Participants in this arm will receive an identical full pulpotomy procedure. However, prior to the placement of the EndoCem cement, the exposed radicular pulp stumps will undergo Er,Cr:YSGG laser biomodulation. The laser will be applied in a non-ablative, biostimulatory mode using specific parameters (e.g., 1.0 W, 20 Hz, 50 mJ, 60% water, 70% air) for a predetermined duration to achieve the biomodulation effect. Following laser application, EndoCem cement is placed and the tooth is restored. This is the experimental arm investigating the adjunctive effect of laser therapy.
干预措施: Er,Cr:YSGG Laser (Device)
结局指标
主要结局
Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)
时间窗: At 6, 12, 24, and 48 hours after the completion of the pulpotomy procedure.
Postoperative pain level will be self-reported by participants using a 100-mm Visual Analogue Scale (VAS). The scale is a horizontal line anchored by two verbal descriptors: "No pain" (0 mm) on the left and "Worst pain imaginable" (100 mm) on the right. Participants mark the line at the point that best represents their pain intensity. A higher score indicates greater pain. The outcome for analysis is the mean VAS score recorded at each specified postoperative time point.
次要结局
- Clinical Success Rate(At 1 week and 6 months post-treatment.)
- Radiographic Success Rate(At 6 months post-treatment.)