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临床试验/NCT07395401
NCT07395401招募中不适用

Clinical and Radiographic Evaluation of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as Filling Materials in Primary Molar Root Canals Prepared by Rotary and Manual Files: (Randomized Control Trial Study)

October University for Modern Sciences and Arts1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
1
主要终点
Radiographic Success

研究概览

简要总结

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of Zinc Oxide Eugenol (ZOE) and Iodoform-Calcium Hydroxide (Metapex) as root canal filling materials in primary molars prepared using either rotary or manual instrumentation techniques. Forty-four teeth from children aged 5-8 years indicated for pulpectomy will be randomly allocated into four equal groups based on the combination of instrumentation method and filling material. Clinical parameters-pain, mobility, and sensitivity-will be assessed using standardized scales, while radiographic outcomes, including root resorption and bone density, will be evaluated using Cone Beam Computed Tomography (CBCT) at baseline, 6 months, and 12 months. The study seeks to determine which obturation material and canal preparation technique yield superior healing, adaptation, and resorption compatible with the physiological process of primary tooth exfoliation. Findings are expected to inform evidence-based selection of endodontic materials and instrumentation methods in pediatric dentistry.

详细描述

Preservation of primary teeth is essential for maintaining proper mastication, speech development, and arch integrity, as well as for preventing psychological and functional complications arising from premature tooth loss. Pulpectomy remains the treatment of choice for irreversibly infected or necrotic primary teeth, yet the complex root canal morphology, resorptive nature of primary roots, and behavioral management challenges make such procedures technically demanding.

An ideal root canal filling material for primary teeth should be antibacterial, biocompatible, radiopaque, and resorbable at a rate consistent with natural root resorption. It must also be easily manipulated, removable if necessary, and capable of hermetic sealing. Among the commonly used materials, Zinc Oxide Eugenol (ZOE) has long been considered the standard due to its antimicrobial and sealing properties; however, its slow resorption and potential for periapical irritation are significant drawbacks. Conversely, Metapex, a premixed iodoform-calcium hydroxide paste, exhibits superior biocompatibility, antibacterial effects, and resorption rates that align more closely with physiological root resorption, making it a promising alternative.

Similarly, biomechanical preparation of root canals can be performed manually or using nickel-titanium (NiTi) rotary systems. Manual instrumentation provides tactile feedback and precision but is time-consuming and operator-dependent. Rotary systems, on the other hand, offer improved efficiency, shaping consistency, and reduced chair time-important factors in managing pediatric patients-though they require training and careful use to prevent over-preparation.

This study will enroll 44 primary molars from cooperative, systemically healthy children aged 5-8 years who are indicated for pulpectomy. The teeth will be randomly allocated into four groups:

Rotary instrumentation with Metapex,

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)

盲法说明

statistician will be blinded

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy cooperative children indicated for partial pulpectomy.
  • Restorable primary molars.
  • No mobility, or external pathological root resorption.

排除标准

  • Uncooperative children.
  • Children with systemic medical illness.
  • More than 2/3 of root resorbed.

研究组 & 干预措施

Arm A: Manual Instrumentation and Metapex

Experimental

Primary molar teeth will undergo pulpectomy using Manual instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).

干预措施: Manual Instrumentation (Procedure)

Arm A: Manual Instrumentation and Metapex

Experimental

Primary molar teeth will undergo pulpectomy using Manual instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).

干预措施: Iodoform-Calcium Hydroxide (Metapex) (Drug)

Arm B: Rotary Instrumentation and Metapex

Experimental

Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).

干预措施: Iodoform-Calcium Hydroxide (Metapex) (Drug)

Arm B: Rotary Instrumentation and Metapex

Experimental

Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with iodoform-calcium hydroxide paste (Metapex).

干预措施: Rotary Instrumentation (Procedure)

Arm C: Manual Instrumentation and ZOE

Active Comparator

Primary molar teeth will undergo pulpectomy using manual instrumentation followed by obturation with zinc oxide eugenol (ZOE).

干预措施: Manual Instrumentation (Procedure)

Arm C: Manual Instrumentation and ZOE

Active Comparator

Primary molar teeth will undergo pulpectomy using manual instrumentation followed by obturation with zinc oxide eugenol (ZOE).

干预措施: Zinc Oxide Eugenol (ZOE) (Drug)

Arm D: Rotary Instrumentation and ZOE

Active Comparator

Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with zinc oxide eugenol (ZOE).

干预措施: Rotary Instrumentation (Procedure)

Arm D: Rotary Instrumentation and ZOE

Active Comparator

Primary molar teeth will undergo pulpectomy using rotary instrumentation followed by obturation with zinc oxide eugenol (ZOE).

干预措施: Zinc Oxide Eugenol (ZOE) (Drug)

结局指标

主要结局

Radiographic Success

时间窗: Baseline, 6 months, and 12 months

Radiographic success will be assessed by evaluating root resorption in treated primary molars. Cone Beam Computed Tomography (CBCT) will be used to measure the degree of root resorption in millimeters, allowing comparison between zinc oxide eugenol (ZOE) and iodoform-calcium hydroxide (Metapex) obturation materials in canals prepared by rotary and manual instrumentation techniques.

次要结局

  • Postoperative Pain(Baseline, 6 months, and 12 months)
  • Tooth Mobility(Baseline, 6 months, and 12 months)
  • Tooth Sensitivity(Baseline, 6 months, and 12 months)

研究者

发起方
October University for Modern Sciences and Arts
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nanis Nasser Anwar Moustafa

teacher assistant at pediatric dentistry department

October University for Modern Sciences and Arts

研究点 (1)

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