Comparison of Post-operative Pain and Levels of MMP -9 Following Root Canal Irrigation With Sodium Hypochlorite Versus Cold Atmospheric Plasma in Patient With Necrotic Single Rooted Teeth: 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
- 60
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
The goal of this clinical trial is to compare the effect of cold atmospheric plasma versus sodium hypochlorite as irrigating solutions in necrotic single rooted teeth. The main questions it aims to answer are:
- Does the use of sodium hypochlorite solution or cold atmospheric plasma as root canal irrigant will have the same effect on the level of postoperative pain in necrotic single rooted teeth?
- Does the use of sodium hypochlorite solution or cold atmospheric plasma as root canal irrigant will have the same effect on the level of MMP -9 in necrotic single rooted teeth? Researchers will compare cold atmospheric plasma to sodium hypochlorite solution as root canal irrigant to see if cold atmospheric plasma works to have the same effect on the level of postoperative pain and levels of MMP -9 in necrotic single rooted teeth.
Participants will:
- be asked to rate their pain level according to the given instructions and will be asked to return for follow up after 2 days to hand the pain scale chart.
- be instructed to call the operator and will be permitted to take Ibuprofen 400 mg not more than 6 hours apart and to record their tablet intake within 48 hours postoperatively, in case of severe or persistent pain.
- be referred to the fixed prosthodontics department for final restoration.
详细描述
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 Interventions
Operator qualifications:
PhD degree candidate.
- Diagnostic procedures:
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 microbiologist will be blinded to the treatment groups.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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)
- •Patient's age between 18-55 years.
- •Male and female patients.
- •Patients who can understand the numerical rating scale (Appendix 4).
- •Patients who accept to participate in the trial and can sign the informed consent (Appendix 1).
- •Mature mandibular premolar teeth with:
- •Negative response to electric pulp tester.
- •No intra-canal calcifications or internal resorptive lesions.
排除标准
- •Medically compromised patients having substantive functional limitations (ASA III or IV) (Appendix 2).
- •Patients having two or more adjacent teeth requiring endodontic treatment.
- •Patients who received antibiotic therapy within the last three months before treatment (Rôças et al., 2016).
- •Patients administered analgesics in the last 24 hours before treatment.
- •Teeth with:
- •Vital pulps.
- •Immature apices.
- •Acute periapical abscess, swellings and facial cellulitis.
- •Periodontally affected (mobility grade II or III).
- •Previous root canal treatment.
- •Non-restorable coronal portion.
- •TMJ problems, bruxism or traumatic occlusion.
- •Inability to perceive the given instructions.
研究组 & 干预措施
Application of cold atmospheric plasma
root canal disinfection protocol
干预措施: Application of cold atmospheric plasma (Other)
2.5% sodium hypochlorite
irrigation solution
干预措施: Application of cold atmospheric plasma (Other)
结局指标
主要结局
Post-operative pain
时间窗: 6,12,24,48 hours and 7 days postoperative following the two visits.
Postoperative pain intensity will be measured at 6, 12, 24 and 48 hours and one week after the two visits following disinfection protocol in the first visit and after obturation in the second visit: Each patient will receive a pain chart containing 4 numerical rating scales; one for each time interval. The patient will be instructed to rate his/her pain level at the corresponding time interval on a scale from zero to 10, where a score of zero indicates absence of pain, a score from 1 to 3 indicates mild pain, a score from 4 to 6 indicates moderate pain and a score from 7 to 10 indicates severe pain (Youssif et al. 2025).
次要结局
- MMP-9 level(After access cavity preparation (S-1), after application of disinfection protocol (S-2) & after one-week pre-obturation (S-3))
研究者
Ahmed Hesham Abdelmohaimen Rezk
principle investigator
Cairo University