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临床试验/NCT03533231
NCT03533231已完成4 期

Efficiency of Triple Antibiotic Mixture and Propolis as Intracanal Medication in Revascularization Process in Immature Apex: A Clinical Study

Tariq Yehia0 个研究点目标入组 40 人开始时间: 2015年1月16日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
主要终点
Change in root length

研究概览

简要总结

This Study Was Made to Evaluate the Antibacterial Effect of Different Antibacterial Combinations on Revascularization Process in Permanent Anterior Immature Teeth. Immature Necrotic Permanent Maxillary Incisors (n = 40) of Patients 8-18 Years Old Were Divided Into 4 Equal Groups (Each n = 10) According to the Intracanal Medicament: Group 1 Was Treated With Triple Antibiotic Paste (TAP), Group 2 Was Treated With Ciprofloxacin + Propolis Paste (CP), Group 3 Was Treated With Ciprofloxacin + Metronidazole Paste (CM), Group 4 Was Treated With Propolis + Metronidazole Paste (PM). Cases Were Followed at Regular Intervals up to 18 Months Clinically and Radiographically.

详细描述

Introduction In the last 10 years, numerous published cases and case series described the revascularization or regenerative endodontics. Revascularization is a conservative method for inducing maturogenesis in necrotic immature teeth. The favorable outcomes of regenerative endodontics are largely dependent on the adequate disinfection of the root canal. These canals with compromised fragile underdeveloped dentinal walls represent a contraindication for mechanical instrumentation; thus, chemical debridement remains the main form of disinfection. A mixture of ciprofloxacin, metronidazole, and minocycline, known as the triple antibiotic paste (TAP), has been shown to be very effective in eliminating endodontic pathogens in vitro and in situ. However, TAP has an adverse effect on stem cell survival. Discoloration of the tooth is a problem mostly related to the use of minocycline in TAP. Moreover, TAP can demineralize dentin resulting in reduced microhardness and fracture resistance. Propolis, a flavonoid-rich resinous product of honeybees, is ten times less cytotoxic than calcium hydroxide and has a well-known antibacterial effect. Therefore, creating alternatives to the TAP for disinfecting the root canal of necrotic teeth during the process of pulp revascularization is thought to be of value.

Materials and methods Forty patients with immature, nonvital maxillary incisors were included in this study from the outpatient clinic of the Faculty of Dentistry, Ain Shams University, Cairo, Egypt. A detailed medical and dental history was obtained from each patient's parents or guardians. Only medically free patients were included in this research. The clinical and radiographic exclusion criteria were teeth with vertical fractures, periodontally involved teeth, and nonrestorable teeth. All procedures were performed after obtaining proper institutional review board approval based on the regulations of the Ethical Committee of the Faculty of Dentistry, Ain Shams University. Intraoral periapical radiographs revealed immature apices. The age of the patients ranged between 8 and 18 years. Informed consent was signed for each case by the patient's parents or guardians including the proposed treatment and possible outcomes or complications.

Cases were divided randomly and equally into 4 groups according to the intracanal medicament (10 patients for each group):

TAP group: was treated with Triple Antibiotic Paste CP group: was treated with Ciprofloxacin + Propolis paste CM group: was treated with Ciprofloxacin + Metronidazole paste PM group: was treated with Propolis + Metronidazole paste

  1. Triple Antibiotic Paste (TAP):

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 (Participant)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Permanent anterior teeth having immature apex.
  • •Established radiographic periapical pathosis.
  • •History of previous trauma.
  • •Compliant patient/parent.

排除标准

  • •teeth with vertical fractures, periodontally involved teeth, and nonrestorable teeth.
  • •Patients with vital teeth.
  • •Patients with heart disease or systemic disorders.

研究组 & 干预措施

Triple Antibiotic Paste (TAP)

Active Comparator

It consisted of Ciprofloxacin (Ciprocin 250 mg tablets; EPICO, Cairo, Egypt), Metronidazole (Flagyl 500 mg tablets; Sanofi Aventis Pharma, Cairo, Egypt), Doxycycline (Vibramycin 100 mg capsules; Pfizer, Cairo, Egypt). One Doxycycline capsule content was evacuated in a sterile mortar, one tablet of metronidazole and one tablet of ciprofloxacin were crushed and ground in the same mortar using a pestle into homogenous powder. Saline drops (Otrivin baby saline; Novartis, Cairo, Egypt) were added and mixed using the pestle until a creamy paste was achieved (Sabrah et al. 2013, Nagy et al. 2014). TAP was then used for canal disinfection.

干预措施: Canal Disinfection Triple Antibiotic Paste (TAP) (Combination Product)

Ciprofloxacin + Propolis Paste

Experimental

Ethanol extract of raw propolis (EEP; ElEzaby Co. Labs, Cairo, Egypt.) was prepared by adding 10 gm of propolis (Imtinan, Cairo, Egypt) to 40 gm of 70% ethanol (ElGomhorya Co., Cairo, Egypt) (for 20% tincture) in a dark container to prevent reduction of propolis. The container was sealed and placed at room temperature for a period of three weeks. The sealed container was manually shaken every 2 days to ensure proper mixing. After 3 weeks, the container was opened and ethanol extract of propolis was obtained. Ethanol-free EEP was made by evaporating the ethanol in a water bath. EEP was then mixed with Ciprofloxacin powder in the ratio 1:1. Saline drops were added and mixed using the pestle until a creamy paste was achieved. This paste was then used for canal disinfection.

干预措施: Ciprofloxacin + Propolis Paste (Combination Product)

Ciprofloxacin + Metronidazole Paste

Active Comparator

Ciprofloxacin powder was mixed with Metronidazole powder in the ratio 1:1. Saline drops were added and mixed using the pestle until a creamy paste was achieved. This paste was then used for canal disinfection.

干预措施: Ciprofloxacin + Metronidazole Paste (Combination Product)

Propolis + Metronidazole paste

Experimental

Ethanol Extract of Propolis (EEP) was mixed with Metronidazole powder in the ratio 1:1. Saline drops were added and mixed using the pestle until a creamy paste was achieved. This paste was then used for canal disinfection.

干预措施: Propolis + Metronidazole paste (Combination Product)

结局指标

主要结局

Change in root length

时间窗: baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

Change in root length on follow up radiographs

Change in root thickness

时间窗: baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

Change in root thickness on follow up radiographs

Change in periapical pathosis

时间窗: baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

Change in periapical bone density on follow up radiographs

Change in apical diameter

时间窗: baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

Change in apical diameter on follow up radiographs

次要结局

未报告次要终点

研究者

发起方
Tariq Yehia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tariq Yehia

Lecturer of Endodontics

Ain Shams University

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