The Impact of Employing Different Kinematics Within a Single-File System on the Perception of Postoperative Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The goal of this clinical trial is to evaluating the influence of single file rotary system for root canal instrumentation using different kinematics on postoperative pain, the primary purpose: measuring post-operative pain by Numerical rating scale in a cohort population treatyed in Jordan Universoit of science and technology post graduate clinics with previously intittaed root canal treatement and could include any of the following: sex/gender, age groups (18-65 ), and healthy volunteers.
The main questions it aims to answer [is/are:
- Is there any difference in postoperative pain after root canal treatment with different kinamtics
- Is this correlated with the level of cytokines measured taken from inside the canal system before and after treament whioch will be analyzed by the ELISA Kit for pain biomarkers.
- Is this related to in vitro debris extrusion, and can it validate previous research with the same methodology for debris extrusion measurement Researchers will compare 5 groups, which are Canal pro jeni, Continuous clockwise rotation (CCR), Optimum Torque Reverse (OTR), Forward reciprocating motion (REC), and Twisted Adaptive motion (TFA). All motions will be used with the One Curve file system Participants will report the level of pain after traatment level of cytokines will be measured by taking samples from the periapical area before, during, and after trematemtn
详细描述
This prospective, randomized, parallel-group clinical trial will evaluate whether the kinematics used during root canal instrumentation with a single-file system influence postoperative pain and the local expression of pain-related neuropeptides. The trial will be conducted in adult patients requiring endodontic treatment of mandibular molars. Eligible participants will be enrolled after clinical and radiographic assessment and after obtaining written informed consent.
Participants will be randomly allocated to one of five treatment groups. In all groups, canal shaping will be performed using the same One Curve nickel-titanium single-file system, while the kinematic motion used to activate the file will differ between groups. The tested kinematics will include CanalPro Jeni motion, continuous clockwise rotation, optimum torque reverse motion, forward reciprocating motion, and twisted adaptive motion. This design allows the effect of instrument motion to be assessed while maintaining the same file system across all study arms.
All treatments will be performed under standardized clinical conditions. Local anesthesia will be administered and the tooth will be isolated with a rubber dam. Access cavity preparation, canal identification, manual scouting, working length determination, and radiographic confirmation will be completed using a standardized approach. Initial irrigation will be performed before instrumentation, and the allocated kinematic protocol will then be used for canal preparation according to the study protocol.
Periapical fluid samples will be collected using sterile paper points at predefined procedural time points. The sampling schedule will include collection during the initial stage of canal preparation, after instrumentation, and at the follow-up visit. Samples will be transferred to sterile tubes and stored under appropriate laboratory conditions until analysis. The collected samples will be analyzed using enzyme-linked immunosorbent assay methods to quantify selected neuropeptides associated with inflammatory pain response, including substance P and calcitonin gene-related peptide.
The clinical treatment will be completed over two visits. At the first visit, the canals will be prepared using the allocated kinematic protocol and irrigated using a standardized irrigation sequence. Intracanal medicament will be placed between visits, and the tooth will be temporized. At the second visit, patient-reported pain and percussion sensitivity will be recorded, the temporary restoration and intracanal medicament will be removed, and periapical fluid will be collected before completion of the final irrigation protocol. The canals will then be dried, obturated using gutta-percha and resin-based sealer, and restored with an adhesive restorative material. A postoperative radiograph will be taken as part of routine treatment documentation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
biomarker analysis technician
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18-65 year
- •Fully mature roots
- •Asymptomatic
- •Not taking neither antibiotics nor analgesics withing last 2 weeks
- •ASA I and ASA II
排除标准
- •patients that are younger or older than the selected age group 18-65 years - Immature roots
- •Symptomatic, presence of sinus tract, fistula, or swelling.
- •patient on medication antibiotics or analgesics withing last 2 weeks -Pregnant women,
- •retreatment cases,
- •allergic reactions
- •resorption in the relevant tooth,
- •periapical abscess,
- •apical resorption, systemic diseases,ASA III-VI
- •inability to understand the treatment procedure
- •Any mesial canals with initial apical file larger than ISO 20
研究组 & 干预措施
canal pro Jeni
motion kinematics by canal pro Jeni
干预措施: canal pro jeni (Device)
Optimum Torque Reverse (OTR)
Motion kinematics by Optimum Torque Reverse (OTR)
干预措施: Optimum Torque Reverse (OTR) (Device)
Continuous clockwise rotation (CCR)
Motion kinematics by Continuous clockwise rotation (CCR)
干预措施: continuous rotation (Device)
Forward reciprocating motion (REC)
Motion kinematics by Forward reciprocating motion (REC)
干预措施: forward reciprocation (Device)
Twisted Adaptive motion (TFA)
Motion kinematics by Twisted Adaptive motion (TFA)
干预措施: Twisted Adaptive motion (TFA) (Device)
结局指标
主要结局
Postoperative Pain
时间窗: Up to 48 hours post-treatment
Pain will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported instrument with scores ranging from a minimum of 0 (no pain) to a maximum of 10 (worst possible pain). Higher scores indicate a worse clinical outcome (more severe pain).
次要结局
- Change in Cytokine Levels(From baseline up to Day 3 post-treatment)
