跳至主要内容
临床试验/NCT06771570
NCT06771570已完成不适用

Postoperative Pain and Periapical Tissue Healing Following XP-Endo Finisher Activated Silver Nanoparticles Final Irrigation in Necrotic Mandibular Molars. A Randomized Clinical Trial

Radwa fath Ahmed1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Post operative Pain

研究概览

简要总结

The success of endodontic treatment derives from the complete elimination of microorganisms capable of causing an intraradicular or extra radicular infection. To achieve a more effective eradication of these microorganisms, endodontic instrumentation must always be implemented with abundant irrigation, which has to achieve chemical, mechanical and biological effects.

The objectives of root canal irrigation are to dissolve vital or necrotic pulp tissues, disrupt endodontic biofilms, neutralize endotoxins and remove the smear layer. Antimicrobial activity and biofilm destruction appear to be the most important objectives targeted towards the etiology of pulp and periradicular infections.

详细描述

The role of microorganisms in periradicular infection has been well established in endodontic literature, signifying that endodontic treatment will be afflicted with a higher chance of failure if microorganisms persist in the canals at the time of root canal Obturation .

Furthermore, anatomic complexities of the root canals as isthmuses, fins, ramifications, lateral Canals, and dentinal tubules make the situation much more difficult; bacteria harboring such areas become inaccessible to mechanical instrumentation, and protected by tissue residues, dentin, serum and dead cells that inactivate or diminish the efficiency of antimicrobial agents.

Sodium hypochlorite (NaOCl) is regarded as the most potent disinfectant in endodontics due to its excellent ability to dissolve vital and necrotic tissues in addition to its antimicrobial activity. However, intracanal irrigants are only effective when in contact with the surface, and they cannot penetrate deep into the surfaces because of anatomic barriers. NaOCl can penetrate into the dentinal tubules by 130 μm, whereas bacteria can penetrate into the dentinal tubules by 1000 μm.

Silver nanoparticles (AgNPs) can also be used for disinfection because of their optimal antimicrobial properties. They are effective against many microorganisms including E. faecalis . Nanomaterials has dimensions of 1- 100nm, presenting small sizes, large surface/area mass ratio and increased chemical reactivity , the small size of nanoparticles offers a larger surface area for a small volume of the particles. This allows them to exert action even when used in small quantities, the action of AgNPs differ according to size, concentration, and time of application. Moreover, the killing effect of AgNPs against gram-negative and grampositive bacteria increases with decreasing particle size.

Silver nano particles release silver ions which have an electrostatic attraction to sulfur proteins, that results in adherence and disruption of the bacterial membrane, Silver ions can also cause the denaturation of DNA and ribosomes directly. AgNPs can also interrupt signal transduction by dephosphorylation of tyrosine residues on the peptide substrates leading to cell death and apoptosis.

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
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Patients between the age group of 20 and 40 years old with no sex predilection, who agree to take partin the study and to sign a written informed consent.
  • Asymptomatic necrotic mandibular molars:non-responsive to thermal pulp testing, with no pain to percussion, and distal root having typeI root canal system.
  • Presence of periapical radiolucency not exceeding 5mm in diameter,confirmed with cone beam computed tomography scans.

排除标准

  • Medically compromised patients, pregnant and lactating females.
  • Patients were using medication such as analgesics or any kind of antiinflammatory drugs, or antibiotics 12 h preoperatively.
  • Teeth with calcified root canals, external or internal root resorptions, periodontal problems as those with mobility greater than Grade I, or pocket depth exceeding 5 mm.
  • Previously endodontically treated teeth, immature with open apex, severe damage and those having associated traumatic occlusion.

研究组 & 干预措施

Group I

Active Comparator

About 16 Persons injected by 5 ml 2.5% NaOCl using conventional Needle Irrigation

干预措施: Silver Nanoparticles Irrigation (Biological)

Group II

Active Comparator

About 16 Persons injected by 5 ml AgNPs using conventional Needle Irrigation.

干预措施: Silver Nanoparticles Irrigation (Biological)

Group III

Active Comparator

About 16 Persons injected by 5 ml AgNPs using XP-Endo Finisher activation.

干预措施: Silver Nanoparticles Irrigation (Biological)

结局指标

主要结局

Post operative Pain

时间窗: 4 days

Following the treatment, patients will be asked to record their pain level on a modified VAS at 4, 24, 48, 72, and 96 h.

次要结局

  • Digital periapical radiographs (DPR)(12 Months)

研究者

发起方
Radwa fath Ahmed
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Radwa fath Ahmed

Assistant Lecturer of Endodontics at Faculty of Dentistry, Deraya University

Faculty of Dental Medicine for Girls

研究点 (1)

Loading locations...

相似试验