Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
详细描述
Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems
- Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer
- In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain
- Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth
- Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain
- Postoperative pain is one way to measure the success of endodontic treatment
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
The blinding of operator is not possible due to the nature of the technique used
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients:
- •Aged 4-6years, Medically free and Cooperative.
- •Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.
- •Pre-operative Radiographic criteria:
- •Absence of internal or external root resorption.
- •Absence of periapical or inter-radicular radiolucencies.
排除标准
- •• Patients:
- •Uncooperative children.
- •Children with systemic disease.
- •Physical or mental disabilities.
- •Refusal of participation.
- •Unable to attend follow- up visits.
- •Refusal to sign the informed consent.
- •Previously accessed teeth.
- •Mobile mandibular primary molars.
- •Pain on percussion.
- •Swelling in the vestibule or on palpation.
研究组 & 干预措施
Group I pulpectomy using single rotary file system
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size
#10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline
干预措施: Fanta AF F one rotary files 20 taper 4 (Device)
Group II pulpectomy using manual files system
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline
干预措施: Manual files (k files ,Mani, Inc., Japan). (Device)
结局指标
主要结局
Post-operative pain
时间窗: At 6, 12, 24, 48 and 72 hours and 1 week after Treatment
: will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present. 1. \- Mild: Pain is present but not distracting; easily ignored. 2. \- Moderate: Pain is distracting; manageable but limits activities. 3. \- Severe: Intense pain; unable to concentrate, requires immediate action or medication
次要结局
- child's behavior level((Immediately after treatment))
- Clinical Success(( At 3, 6, 12 months))
- Instrumentation time((During procedure start from anathesia till end of procedure))
- The obturation quality((Immediately after treatment))
研究者
Mona Adel Amer
Candidate in Department of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University
Cairo University