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临床试验/NCT06675058
NCT06675058尚未招募不适用

Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study

Cairo University0 个研究点目标入组 50 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)

研究概览

简要总结

The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.

详细描述

A selective case study design will be employed, focusing on primary molars with either occlusal or proximal carious lesions. Children aged between 3 to 7 years meeting the inclusion criteria will be examined clinically and radiographically to assess the extent and location of the carious lesion. Two groups will be involved in the study; primary molars will be submitted to each group based on whether the lesion is proximal or occlusal. Both groups will then receive indirect pulp therapy, and a clinical and radiographic evaluation for one year will be conducted.

The purpose of this study is to examine how the location of caries, whether proximal or occlusal, affects the success rate of IPT in primary molars. Understanding this relationship is essential for developing more tailored clinical approaches in pediatric dentistry to ensure long-term treatment success.

研究设计

研究类型
Interventional
分配方式
Non 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
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Participant criteria:
  • •Children aged between 3-7 years
  • •Children in complete physical and mental health.
  • •Children with free medical history.
  • •Patient with favorable attitudes, which will be assessed by using Frankl behavior rating.
  • •Teeth criteria:
  • •Primary molars with active occlusal or proximal deep caries.
  • •Teeth with reversible pulpitis
  • •Asymptomatic teeth or teeth with provoked pain of short duration
  • •Teeth should be restorable.

排除标准

  • •Clinical signs or symptoms suggesting evidence of pulp degeneration or a non -vital tooth such as:
  • •Clinical symptoms or history indicating irreversible pulpitis as (spontaneous pain, throbbing pain).
  • •Tenderness to percussion.
  • •Soft tissue swelling, abscess, draining fistula or sinus tracts.
  • •Pathological Tooth mobility.
  • •Presence of the following Radiographic criteria:
  • •Periapical or inter-radicular radiolucency.
  • •Internal or external pathological root resorption.
  • •Furcation involvement
  • •Widening of periodontal space.

研究组 & 干预措施

Primary teeth with deep proximal caries

Experimental

In primary molars with deep proximal caries indirect pulp treatment will be performed by removing infected dentin while affected dentin in pulpal floor will be left in place. Teeth will be capped by a dressing material.

干预措施: Indirect Pulp Treatment (Procedure)

Primary teeth with deep occlusal caries

Active Comparator

In primary molars with deep occlusal caries also IPT will be performed. Soft infected dentin will be carefully removed until the dried, hardened affected dentin with a leathery consistency reached then teeth will be capped by a dressing material

干预措施: Indirect Pulp Treatment (Procedure)

结局指标

主要结局

Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)

时间窗: one year follow up

Clinical success rate will be assess through assessment of the following : Post-operative Pain (percentage of absence of pain), Presence or absence of clinical signs (e.g., swelling, abscess, sinus tract), and Pain on Percussion

次要结局

  • Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).(one year follow up)

研究者

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

Yomna Hussein Moselhy Sayed Ahmed

Dr. Yomna Hussein Moselhy

Cairo University

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