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临床试验/NCT03504332
NCT03504332Unknown3 期

Clinical and Radiographic Evaluation of Calcium Hydroxide and Bi-antibiotic Paste as Anti-microbial Dressing in Revascularization of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 56 人开始时间: 2018年6月最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
56
主要终点
Pain

研究概览

简要总结

The object of this study is to compare the effect of Calcium Hydroxide and Di-antibiotic paste as intracanal disinfectants in the 1st visit of revascularization of necrotic immature permanent anterior teeth.

详细描述

Dental trauma is common in children and it is the main cause of loss of pulp vitality in immature permanent anterior teeth with prevalence rate of 11% and about of 27% of traumatized anterior teeth are left untreated.

Dentists face many challenges during the treatment of infected immature permanent teeth. This is mainly due to the thin dentinal walls of the root and blunderbuss apices that make these teeth susceptible to fracture during and after treatment.

Traditionally, Calcium Hydroxide apexification has been the only method for managing these cases.. however, it was found that this technique caused additional reduction in root strength due to the long-term application of Calcium Hydroxide which may end in fracture of the tooth. The time needed for complete apexification using Calcium Hydroxide was reported to be variable ranging from 5 to 20 months, with failure rate 0f 30% . Therefore, this technique is no longer recommended for the treatment of such cases.

A recently proposed technique for the treatment of immature necrotic permanent teeth is revascularization regenerative endodontic therapy (RET). It is a biologically based technique that allow the continuation of root development and thickening of dentinal walls. This is achieved through proper disinfection o the root canal system, creation of scaffold and perfect coronal seal.

For proper disinfection of the root canal system, antibiotic paste was applied as intracanal dressing for 2-3 weeks. However, the recent recommendations by the European society of Endodontology advices the use of Calcium Hydroxide as intracanal medication instead of intracanal antibiotics. This is because of some concerns regarding the use of antibiotics which include: cytotoxicity to stem cells needed for the revascularization process, risk of antibiotic resistance and the risk of sensitization. Calcium Hydroxide on the other hand is widely used as intracanal disinfectant and some studies were found supporting its use in the revascularization technique, [9, 10]. However, the data available is not sufficient regarding the effectiveness of Calcium Hydroxide in revascularization of necrotic pulp.

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
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Immature anterior teeth with open apices.
  • Necrotic teeth (regardless the cause of pulpal involvement: Caries, trauma or congenital anomalies).
  • Children free from any systemic diseases that may interfere with the normal healing process.

排除标准

  • Children Allergic to antibiotics to be used in the study.
  • unooperative children.
  • Laxative injuries.
  • Compromised remaining tooth structure.
  • internal or external root resorption

研究组 & 干预措施

Calcium Hydroxide in revascularization

Experimental

Revascularization of necrotic anterior teeth: canals disinfection step. Pure Calcium Hydroxide powder mixed with saline will be placed as intra-canal medication in the 1st visit of dental pulp revascularization.

干预措施: intracanal disinfection in revascularization (Procedure)

Di-antibiotic paste in revascularization

Active Comparator

Revascularization of necrotic anterior teeth: canals disinfection step. Mix 1:1 ciprofloxacin: metronidazole to a final concentration of 0.1 mg/ml, placed as intra-canal medication in the 1st visit of dental pulp revascularization.

干预措施: intracanal disinfection in revascularization (Procedure)

结局指标

主要结局

Pain

时间窗: baseline.

Binary outcome (present/ absent). Assessed by asking the patient

Change in pain

时间窗: at 6 and 12 months

Binary outcome (present/ absent). Assessed by asking the patient.

次要结局

  • Pain on percussion(baseline and for 1 year follow up)
  • Swelling(baseline and for 1 year follow up)
  • Sinus or fistula(baseline and for 1 year follow up)
  • Root Lengthening(baseline and for 1 year follow up)

研究者

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

Reem Mohamed Fouad Wahby

Principal Investigator

Cairo University

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