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临床试验/NCT07319741
NCT07319741尚未招募不适用

Clinical and Radiographic Evaluation of Single Visit Pulpectomy in Primary Molars for (5-7) Years Old Children Using Rotary and Manual Instrumentation: A Randomized Clinical Trial

Anfal mohamed elmotaz almogtaba1 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1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Clinical success of Pulpectomy procedure

研究概览

简要总结

This study will evaluate the clinical and radiographic outcomes of rotary versus manual pulpectomy in children with irreversible pulpitis.A single-visit pulpectomy will be performed for all patients. Participants will be allocated to rotary instrumentation using Fanta AF Baby files or manual step-back instrumentation with K-files. Canals will be irrigated with 17% EDTA and 1% sodium hypochlorite, obturated with Metapex, and restored with glass ionomer cement and stainless-steel crowns. Primary outcomes will assess clinical success at 3, 6, 9, and 12 months, while secondary outcomes will evaluate postoperative pain and radiographic success at 6 and 12 months.

详细描述

In this study, the principal investigator will screen participants to ensure eligibility and obtain comprehensive medical and dental histories from their parents or legal guardians, along with informed consent. All participants will undergo thorough clinical and radiographic examinations to confirm a diagnosis of irreversible pulpitis and suitability for pulpectomy. Local anesthesia will be administered, followed by caries removal, access cavity preparation, and pulpal extirpation. Working length will be determined radiographically, and participants will be allocated into two groups based on instrumentation technique: Group 1 will receive rotary instrumentation using Fanta AF Baby files with a crown-down approach, while Group 2 will undergo manual instrumentation using K-files with a step-back technique. Irrigation will involve 17% EDTA gel and 1% sodium hypochlorite, and canals will be obturated with Metapex, followed by restoration with glass ionomer cement and stainless-steel crowns in the same visit. The primary outcome will assess clinical success at 3, 6, 9, and 12 months post-treatment, defined by the absence of soft tissue swelling, tenderness, sinus tract, fistula, or pathological mobility. Secondary outcomes will include evaluation of postoperative pain intensity using a modified Wong-Baker Pain Rating Scale and radiographic success at 6 and 12 months, defined by the absence of root resorption, periodontal ligament widening, or periapical/furcal radiolucency.

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, Care Provider, Outcomes Assessor)

盲法说明

The co-supervisor and main supervisor will also be masked.

入排标准

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

入选标准

  • Children aged 5-7 years with irreversible pulpitis of primary molars.
  • History of spontaneous pain with a deep carious lesion.
  • Parents who approve to write informed consent.

排除标准

  • Medically compromised children.
  • Children with a history of allergic reaction to the materials used in the study.
  • Children with non-restorable teeth.
  • Teeth with resorbed roots (more than two-thirds of root length).
  • Extensive internal or external root resorption visible in periapical Radiographs.

研究组 & 干预措施

Group2: Single-visit pulpectomy using manual instrumentation

Active Comparator

This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using manual instrumentation

干预措施: Manual Instrumentation (Procedure)

Group 1: Single-Visit Pulpectomy using Rotary instrumentation

Active Comparator

This group will include patients with irreversible pulpitis who will undergo single-visit pulpectomy using rotary instrumentation

干预措施: Rotary Instrumentation (Procedure)

结局指标

主要结局

Clinical success of Pulpectomy procedure

时间窗: 12 months

The primary outcome of this study will be the assessment of clinical success of the both instrumentation techniques (Manual and Rotary instrumentation), evaluated at 3, 6, 9, and 12 months post-treatment. Clinical success will be defined based on binary assessment by the absence of soft tissue swelling, tenderness to percussion (Performed by the back of the mirror), sinus tract, fistula, and pathologic mobility

次要结局

  • Evaluation of Radiographic Success of Pulpectomy(12 months)

研究者

发起方
Anfal mohamed elmotaz almogtaba
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anfal mohamed elmotaz almogtaba

Master's student

Cairo University

研究点 (1)

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