跳至主要内容
临床试验/NCT06640231
NCT06640231招募中不适用

The Effect of XP-Endo Finisher Activation of Bioceramic Sealer on Postoperative Pain in Mandibular First Molar With Symptomatic Irreversible Pulpitis

Future University in Egypt2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Post-operative pain after sealer activation with XP-Endo Finisher in comparison to without sealer activation

研究概览

简要总结

The aim of endodontic obturation is to make a complete sealing along the length of the root canal system to ensuring the peri radicular tissue healing and sustained health. Disadvantages of gutta-percha-based root filling materials is lack of adhesiveness to canal wall dentin. So, a sealer or cement has to be used with gutta-percha to achieve a fluid-tight seal and fill the space between the canal wall dentin and the obturating material.

Drawbacks of resin-based sealer are difficult preparation technique of deep root canal cavity which also limit dentin bonding, difficult to be removed from the canal in retreatment cases and its shrinkage during setting.

Bio-ceramic root canal sealers become popular in recent years because of their unique chemical and physical properties. These sealers are consisting of biocompatible materials that resemble the of tooth structure natural composition so bio-ceramic sealers are an ideal choice for root canal treatment. Bio-ceramic sealers are better than traditional sealers due to their multiple physical properties for example excellent sealing ability, dimensional stability, and low solubility. These properties ensure that the sealers achieve a tight seal, inhibiting bacterial leakage and decreasing the risk of reinfection. Diaroot Bioaggregate (DiaDent), a white nanoparticle-sized ceramic cement composed of calcium silicate, calcium hydroxide and hydroxyapatite and considered a modified version of MTA, with the advantage of being aluminium-free in composition, a fact that contributes to its greater biocompatibility with periradicular tissue.Root canal sealers activation may improve their penetration into dentinal tubules and improve sealability and antimicrobial effects.

Recently, a non-tapered nickel-titanium rotary instrument (XP-endo Finisher; FKG, La Chaux-de-Fonds, Switzerland) has been designed to increase the efficiency in root canal wall cleaning specifically with limited impact on dentine throughout the literature, XP efficacy in decreasing microorganisms, dissolving organic tissue from artificial cavities in combination with NaOCl and penetrating into the isthmus has been analyzed.

The aim of this study to evaluate the effect of XP-Endo Finisher activation of Bioceramic sealer on postoperative pain in mandibular first molar with symptomatic irreversible pulpitis.

This study consists of 30 patients divided into 2 group each group having 15 patients.

Intervention:

Bioceramic sealer activation with XP Endo Finisher.

Control group:

Bioceramic sealer without activation.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ranges from 18 to 40 years old.
  • No sex predilection.
  • Patients seeking root canal treatment.
  • Systematically healthy patient (ASA I, II).
  • Patient who can understand numerical rate scale and sign an informed consent.
  • Mandibular first molar teeth with:
  • Preoperative sharp (moderate or severe) pain.
  • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
  • Normal periapical radiographic appearance.

排除标准

  • Patients with American association of anesthesiologists (ASA) classification other than ASA T& II.
  • Patients who have already ingested preoperative medication, such as analgesics, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
  • Patients with NSAIDs allergy.
  • Patients having two or more adjacent teeth needing root canal therapy.
  • Pregnant patients.
  • Patients with bleeding disorder.
  • Patients with long term corticosteroid use
  • Teeth having;
  • Necrotic pulp.
  • History or presence of swelling or fistulous tract.
  • Acute / chronic periapical abscess.
  • Mobility more than grade
  • Pocket depth more than 5mm.
  • No possible restorability.
  • Previous root canal treatment.
  • Periapical radiolucency.
  • External or internal resorption.
  • Vertical root fracture.
  • TMJ problems, bruxism, clenching or traumatic occlusion.
  • Inability to understand and perform the given instructions.

结局指标

主要结局

Post-operative pain after sealer activation with XP-Endo Finisher in comparison to without sealer activation

时间窗: Immediately after obturation, 6-, 12-, 24- and 48-hours post-operative.

Measuring of post-operative pain by Numerical rate scale(NRS) and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).

次要结局

  • Number of analgesic tablets taken after endodontic treatment with sealer activation in comparison to without sealer activation(Up to 48 hours postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Ali Fahmy Heteba

Principal Investigator

Future University in Egypt

研究点 (2)

Loading locations...

相似试验

The Effect of XP-Endo Finisher Activation of... | 临床试验