跳至主要内容
临床试验/NCT03209115
NCT03209115Unknown早期 1 期

Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicamentson Postoperative Flare -up Following Two-Visit Endodontic Retreatment Cases

Cairo University0 个研究点目标入组 24 人开始时间: 2017年7月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
24
主要终点
Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain

研究概览

简要总结

Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases

详细描述

  1. Each patient will be anesthetized with the same solution, 40 mg articaine hydrochloride + 0.006 mg/mL epinephrine hydrochloride (Ultracaine DS; Aventis Pharma, Istanbul, Turkey).
  2. The standard procedure for each group at the first appointment included rubber dam isolation,removing of previous coronal restorations, and root canal filling materials. The removal of previous root canal fillings will be performed with one of these: Gates Glidden drills, hand files, heated pluggers, and Ni-Ti rotary instruments.
  3. After the removal of previous root canal fillings, the working lengths were determined by apex locator and periapical radiographs 1 mm from the apexes.
  4. Chemo-mechanical preparation of root canals will be made with the master apical files ranged from #25 to #70 depending on the initial diameter or preparation of the root canals.

Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation was made by saline, and the root canals were dried with paper points. 5. In the 1st group the root canals will be medicated with a calcium hydroxide paste for 7 days.(calcium hydroxide injectable paste Metapex , 2.2g paste in a 1 syringe).

In the 2nd group the root canals will be medicated with a calcium hydroxidechlorhexidine paste for 7 days. The paste consists of 1.2 g Ca(OH)2 powder per 1 mL 0.2% chlorhexidine in water. The teeth in both groups will be closed with a sterile dry cotton pellet and a minimum of 3 mm of temporary restorative material. 6. In the next appointment, the tooth was reopened, the intra-canal paste will be removed and a patency file (size 08 Flexofile; Dentsply-Maillefer) was pushed through the foramen.

Master apical file will be checked again and then master cones will be placed and radiographed. Obturation will be done using lateral compaction technique with AD seal resin sealer using spreader for placement of auxiliary cones.

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, Care Provider)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' needs retreatment.
  • Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
  • Age range is between 20 and 50 years.
  • Patients who can understand the categorical tool (points)for measurement
  • Patients able to sign informed consent.

排除标准

  • Complicating systemic disease
  • Having severe pain and/or acute apical abscesses
  • Being under 18 years of age
  • Using antibiotics or corticosteroids

研究组 & 干预措施

calcium hydroxide and chlorhexidine

Active Comparator

Removal of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication

干预措施: combination of calcium hydroxide and chlorhexidine (Drug)

calcium hydroxide

Active Comparator

Removal of old root canal filling and placing calcium hydroxide as intracanal medication

干预措施: Calcium Hydroxide (Drug)

结局指标

主要结局

Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain

时间窗: 7 days

categorical ( 4 points) 1. no pain 2. Mild pain: recognizable but not discomforting pain that required no analgesics. 3. Moderate pain: discomforting but bearable pain(analgesics if used were effective in relieving pain) 4. Severe pain: difficult to bear (analgesics were effective in relieving pain). Patients with severe postoperative pain and/or occurrence of swelling were classified as flare-ups.3 Objectively : percussion test

次要结局

未报告次要终点

研究者

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

Hind Midhat AbdulGader Hussein

principle investigator

Cairo University

相似试验