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临床试验/NCT06420583
NCT06420583尚未招募不适用

Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction for the Management of Permanent First Molar With Poor Prognosis: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
1
主要终点
Post operative pain

研究概览

简要总结

The goal of this clinical trial is to compare between post operative pain and oral health related quality of life in participants receiving two treatments for first permanent mandibular molars with poor prognosis.

Group I (Experimental group): Complete Pulpotomy with the use of MTA followed by stainless steel crown.

Group II (Control group): Non-surgical extraction.

详细描述

The principal investigator will carry out all treatment procedures, and the patients will be assigned.

For both interventions:

  1. Informed consent from participating parents.
  2. Baseline records photographs, percussion test, periapical and panoramic radiographs, and personal data collection.
  3. A diagnostic chart with personal, medical, and dental history will be filled
  4. Baseline Oral Health related quality of life questionnaire for each participant.
  5. A clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
  6. Preoperative and Postoperative photographs will be taken.
  7. The radiographic examination will be performed by taking a periapical radiograph and a Panoramic radiograph through a machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using an X-ray holding device.
  8. Preoperative and postoperative radiographs in the pulp therapy group will be taken by a parallel technique using an XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland).
  9. Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows:
  10. Administration of inferior alveolar nerve block and long buccal infiltration: Septocaine® and epinephrine 1:100,000 (Articaine HCl. 4% and Epinephrine 1:100,000 Injection) at the side of the affected tooth.

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
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 8 years and 9.5 years.
  • Decayed Mandibular Permanent first molars.
  • Symptomatic Mandibular permanent first molar (caries-related pulpal symptoms or hypersensitivity relating to enamel hypo mineralization)

排除标准

  • Children who are not apparently healthy.
  • Lack of informed consent by the child patient's parent.
  • Patients who are allergic to any of the materials used in the procedure.
  • Unable to attend follow-up visits.
  • Refusal of participation.

结局指标

主要结局

Post operative pain

时间窗: 24 hours post operatively

will be measured using visual analog scale (VAS) The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.

次要结局

  • Oral health related quality of life(12 months)

研究者

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

Aya Amr Abo ElMagd

principle investigator

Cairo University

研究点 (1)

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