Effect of Local Use of Non-steroidal Anti-inflammatory Agent (Diclofenac Sodium) With and Without Hyaluronidase on Post-surgical Pain and Swelling: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
The goal of this clinical trial is to evaluate whether locally applied diclofenac sodium, with or without hyaluronidase, can reduce post-surgical pain and swelling in adult male and female patients (18 years or older) with asymptomatic single-rooted teeth and periapical lesions (5-10 mm in diameter). The main questions it aims to answer are:
Does local application of diclofenac sodium reduce postoperative pain and swelling compared to no medication?
Does the combination of diclofenac sodium and hyaluronidase offer greater reduction in postoperative pain and swelling than diclofenac sodium alone?
Researchers will compare four groups (diclofenac only, hyaluronidase only, diclofenac + hyaluronidase, and no medicament) to see if the medicated groups experience significantly less pain and swelling after periapical surgery compared to the control group.
Participants will:
Undergo root canal treatment followed by periapical surgery in a single visit.
Receive a randomly assigned intra-osseous gel (diclofenac, hyaluronidase, both, or none) placed into the surgical cavity.
Record their postoperative pain using a visual analogue scale at specified intervals (6, 12, 24, 48 hours, and 7 days).
Return for clinical assessments of swelling at 24, 72 hours, and 5 days post-surgery
详细描述
A) Participants, interventions & outcomes 9. Study settings: The study will be carried out in the endodontic clinic at the faculty of dentistry, Cairo University, Cairo governorate, Egypt.
- The dental Unit is ADEC 200 USA.
- The X-ray machine is FONA XDC, Italy.
- The X-ray sensor plate: Digora intraoral digital sensor plate, Soredex, USA.
- The operator is a PhD student in the department of Endodontics.
- Time: 2025 10. Eligibility criteria:
Inclusion criteria:
- Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II, with no known allergic manifestations to the drugs used in the study and no involvement with other medication during the study (Appendix 2).
- Patients who are 18 years of age or older, without underlying chronic systemic conditions.
- Male and female patients.
- Patients having asymptomatic single rooted teeth with periapical lesions 5-10mm in diameter (Appendix 3).
- Patients who can understand the visual analogue scale (Appendix 4).
- Patients who accept to participate in the trial and can sign the informed consent (Appendix 1).
Exclusion criteria
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II, with no known allergic manifestations to the drugs used in the study and no involvement with other medication during the study (Appendix 2).
- •Patients who are 18 years of age or older, without underlying chronic systemic conditions.
- •Male and female patients.
- •Patients having asymptomatic single rooted teeth with periapical lesions 5-10mm in diameter (Appendix 3).
- •Patients who can understand the visual analogue scale (Appendix 4).
- •Patients who accept to participate in the trial and can sign the informed consent (Appendix 1).
排除标准
- •Teeth with pathosis associated with vertical root fractures, teeth with coronal perforations, and periodontal pockets (7 mm).
- •Miller class III/IV mobility, compromised crown-to-root ratio, combined endodontic-periodontic lesions
- •Systemic medical diseases and autoimmune diseases
- •Pregnant females
- •Patients allergic to Diclofenac or Hyaluronidase
- •Teeth with previous root canal therapy
研究组 & 干预措施
Different types of medications placed in the osseous cavity after root end resection
I1: Diclofenac sodium : 1 mL of gel, of 1 mL of 3 mL/75 mg Diclofenac sodium and 1% Carbopol 940 gel base, will be passively placed in the osseous cavity I2: Hyaluronidase : 1 mL of gel, of 1 ampoule (1500 IU) Hyalase powder in 2.5 mL of 0.9% sodium chloride, and 1% Carbopol 940 gel base, will be passively placed in the osseous cavity I3: Diclofenac sodium and Hyaluronidase: 1 mL of gel, of 1 ampoule (1500 IU) Hyalase powder and 1 ampoule (3 mL/75 mg) of Diclofenac sodium, Carbopol 940 gel base, will be passively placed in the osseous cavity
干预措施: Diclofenac Sodium Gel (Drug)
结局指标
主要结局
Postoperative pain intensity
时间窗: 6,12,24, 72 hours and 1 week post-surgical procedure
Postoperative pain intensity measured at 6,12,24, 72 hours and 1 week post-surgical procedure: Each patient will receive a pain chart containing a 10-cm visual analogue scale (VAS), one for each time interval. The patient will be instructed to rate his/her pain level at the corresponding time interval on a 10-cm visual analogue scale (VAS), scored between 0 (no pain) and 10 (the most unbearable pain). Metin et al. (2018)
次要结局
- Postoperative swelling(24,72 hours and 5 days)
研究者
Mariam Hesham Mahmoud Abdelfattah Eissa
Principle investigator
Cairo University