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临床试验/NCT06137391
NCT06137391尚未招募不适用

Effectiveness of Partial Pulpotomy and Pulpotomy in Symptomatic Deeply Carious Permanent First Molars With Molar Incisor Hypomineralisation (24 Months Randomised Controlled Clinical Trial)

Alexandria University0 个研究点目标入组 96 人开始时间: 2024年1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
96
主要终点
Cone Beam Computed Tomography scans

研究概览

简要总结

Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy.

The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months.

详细描述

Pediatric dentists frequently encounter deeply carious young permanent first molars (PFM) with Molar Incisor Hypomineralisation (MIH). Pulpal status of affected PFM was found to be different from that of unaffected PFMs which consequently might influence the pulpal response after vital pulp therapy. The aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic PFM affected with MIH over 24 months. In this prospective randomized controlled clinical trial, a randomized assigned sample of 96 children each with a deeply carious young PFM, Group I (n=48) diagnosed with MIH and irreversible pulpitis and Group II (n=48) diagnosed with irreversible pulpitis but not affected with MIH. Group I will be randomly equally allocated into Group II A (n=24): partial pulpotomy (PP) and Group I B (n=24): full pulpotomy (FP). Group II will also be randomly equally allocated into Group II A (n=24): PP and Group II B (n=24): FP. If pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. The pulpotomy agent to be used will be mineral trioxide aggregate (MTA) and teeth will be restored using a resin modified glass ionomer restoration (RMGIC). Teeth will be followed up clinically and radiographically using periapical x-rays for 24 months. Cone beam computed tomographic scans will be taken initially and at 24 months. Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale. All data will be statistically analyzed and discussed considering the results obtained.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 7-13-year-old children.
  • At least one deeply decayed first permanent molar, checked through periapical x-ray)
  • Noncontributory medical history.
  • The tooth should be showing irreversible pulpitis signs and symptoms.
  • The tooth is restorable and probing pocket depth and mobility within normal limits.
  • No signs of pulpal necrosis including sinus tract or swelling.

排除标准

  • Non-restorable teeth.
  • Negative response to cold testing.
  • Presence of sinus tract or swelling.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled after partial pulpotomy in 6 minutes.
  • Insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially necrotic.
  • History of analgesic intake 3 days prior to the day of commencement of procedure.

结局指标

主要结局

Cone Beam Computed Tomography scans

时间窗: Day 0, 24 months

Cone Beam Computed Tomography scans will be taken initially and at 24 months only to avoid excessive radiation dose

Pain assessment

时间窗: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

Pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale, with 0 representing no pain and 100 representing pain as bad as it could be

Digitalized periapical Radiographs

时间窗: Day 0, then at 6, 12, 18 and 24 months.

Standardized digitalized periapical radiographs will be taken.

次要结局

未报告次要终点

研究者

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

Rodaina Helmy

Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry

Alexandria University

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