Influence of Occlusal Reduction on Endodontic Postoperative Pain: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- impact of occlusal reduction on post-operative pain after single-visit root canal treatment by using the visual analog scale (VAS).
研究概览
简要总结
This study aims to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed).
详细描述
A randomized clinical trial will take place at the postgraduate endodontic clinic department at JU Hospital to assess the effect of occlusal reduction on post-operative pain. Participants will be enrolled from the pool of patients referred to the department of endodontics at JUH for root canal treatment, and the trial will be carried out on those diagnosed with necrotic pulps or previously initiated (accessed) teeth.
Patients will undergo root canal treatment by postgraduate students, under rubber dam, and using the dental operating microscope.
At the completion of endodontic treatment, the numbered, sealed, randomization envelope will be opened by the operator, and patient allocation will be revealed.
Access cavity will be sealed with Glass ionomer restoration, then patients will be allocated to either undergo occlusal reduction (Intervention group) where all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur, or not undergo occlusal reduction (Control group) where all occlusal contacts will remain intact.
The presence or absence of contact will be confirmed using articulating paper where occlusal surfaces will be dried and articulating paper will be held between the teeth with the mandible guided to the centric position. Intact occlusion will be assessed by examining the marks on the teeth.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy subjects (ASA I&II) between the age of 18 and 70 years
- •Patients diagnosed with necrotic pulp or previously initiated (accessed).
- •Posterior maxillary or mandibular molar tooth.
- •Presence of an opposing tooth (or teeth) with normal occlusal contact with the opposing tooth (or teeth).
- •Tooth needs cuspal coverage.
排除标准
- •Pregnant females.
- •Patients with significant medical conditions (ASA III & IV).
- •Reported bruxism or clenching.
- •Took analgesics\antibiotics or other drugs that might alter their pain during the last 12 hours preoperatively.
- •A history of allergic reactions to any of the medications and/or materials used.
- •Patients with a tooth that had no contacts or premature contact, fewer than three teeth on one side of the jaw.
- •Greater than grade I mobility or pocket depth greater than 5mm.
- •Non-restorable crowns, severely curved root canals, or post-treatment endodontic disease were, also, excluded.
研究组 & 干预措施
occlusal reduction (Intervention group)
all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur.
干预措施: Occlusal Reduction (Procedure)
no occlusal reduction (Control group)
all occlusal contacts will remain intact.
结局指标
主要结局
impact of occlusal reduction on post-operative pain after single-visit root canal treatment by using the visual analog scale (VAS).
时间窗: from the enrollment of the patient up to 1 week for each patient
to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed) by using visual analog scale (VAS) at 6, 24, 48 hours, and 1 week following the treatment. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represented their level of pain. Pain level was assigned to one of four categorical groups: None (0); Mild (1-3); Moderate (4- 6); Severe (7-10). The scale was explained visually, verbally and numerically to facilitate its use by the participants. This will be done by calling the patients by phone to record the degree of pain at these intervals as explained in the study description.
次要结局
未报告次要终点
研究者
Abdulrahman Mwaffaq Kahhaleh
Masters studnet
University of Jordan