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临床试验/CTRI/2024/02/062626
CTRI/2024/02/062626尚未招募4 期

Comparison of clinical efficiency of two tooth coloured, 3D printed resin crowns: the endocrowns and the full coverage crowns, versus stainless steel crowns for primary molars – an observational study.

Dr Aroonika Bedre1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年2月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
The functional, biological and aesthetic properties of 3D printed resin endocrowns and full coverage crowns are comparable to that of stainless steel crowns.

研究概览

简要总结

45 teeth fulfilling the inclusion criteria will be included in the study and randomly sorted into Group A, Group B and Group C (control). Detailed medical history, clinical examination and necessary radiographic investigation will be done. Informed consent will be obtained. Pulpectomy will be performed in the primary molars. 3D printed resin endocrowns will be cemented in 15 teeth (Group A ), 3D printed full coverage crowns will be cemented in 15 teeth (Group B) and stainless steel crowns will be cemented in 15 teeth (Group C). Revised FDI criteria will be used to assess the functional, biological and aesthetic properties of the crowns at 1, 3 and 6 months. Periodontal health will be assessed using the plaque index (PI) and Gingival Index (GI) at 1, 3 and 6 months. Intergroup comparison of clinical efficiency will be computed by Chi – square test. Repeated ANOVA test will be done to analyze the data collected at 1, 3 and 6 months. Intergroup comparison of plaque and gingival scores will be computed using independent t test.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 4 to 8 years falling under Frankl’s behavior rating scale criteria 2, 3 and
  • Presence of at least one carious maxillary or mandibular primary molar indicated for pulpectomy.
  • Primary molars with irreversible pulpitis or non-vital pulp which show a restorable tooth structure (adequate sound coronal tooth structure) and have an adequate periodontal support which is confirmed by periapical radiographic examinations.
  • Children whose parents gave consent to participate in the study.

排除标准

  • Children with special health care needs.
  • Children with underlying any systemic conditions.
  • Children who are allergic to local anaesthesia or any of the materials used in the study.
  • Teeth which show extensive mobility, and advanced root resorption or other indications for extraction 5) Carious teeth exhibiting pre shedding mobility.
  • The presence of bone rare fraction involving more than a half of the root, severe mobility or resorption of more than half of the root or root perforations.
  • Tooth with underfilled or overfilled obturation.

结局指标

主要结局

The functional, biological and aesthetic properties of 3D printed resin endocrowns and full coverage crowns are comparable to that of stainless steel crowns.

时间窗: 1, 3 and 6 months

次要结局

  • The periodontal health of primary molars restored with 3D printed endocrowns and full coverage crowns are comparable to that of stainless steel crowns.(1, 3 and 6 months.)

研究者

发起方
Dr Aroonika Bedre
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aroonika Bedre

SRM dental college, ramapuram

研究点 (1)

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