跳至主要内容
临床试验/CTRI/2018/05/014019
CTRI/2018/05/014019尚未招募2 期

Comparative Evaluation of Clinical performance of Endodontically treated teeth restored with Short-Fiber reinforced and Zirconia reinforced composite resins as core material – An In vivo Study

Self1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
Self
入组人数
100
试验地点
1
主要终点
To provide proper marginal adaptation, restoration integrity and prevent tooth fracture.

研究概览

简要总结

This study is to compare the clinical performance of endodontically treated teethrestored with short-fiber reinforced composite and zirconia reinforcedcomposite resin as core material. A 100 patients diagnosed withirreversible pulpitis will be chosen according to inclusion and exclusioncriteria from the out-patient block, Department of Conservative Dentistry andEndodontics, SRM Dental College. And the patients divided into 2 groups, group1fiber reinforced composite and group 2 zirconia reinforced composite, A standardized endodontic procedureperformed using rotary instruments and the canals will be obturated usingstandardized GP points and AH Plus resin sealer. Following obturation, the pulp chamber will be cleared of sealer, guttapercha up to 1 mm apical into the root canal orifice, following which postendodontic restoration will be done based on the group. The post-endodontic restorations will be clinically evaluated immediatelyand in recall visit by two calibrated examiners, blinded to the materials usedand any disagreements during evaluation will be resolved by consensus among theexaminers. Modified US Public Health Service (USPHS) criteria will be usedby calibrators for recall evaluation for a period of 1,3, 6, 12 and 24months. Evaluation of the functional restorations willbe done in terms of marginal discoloration and adaptation, restorationintegrity, secondary caries and tooth/restoration fracture. The obtained datawill be tabulated and statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
16.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients willing to actively participate in this in vivo study for periodic follow-ups will be selected.
  • 2.Patients age from 16 to 45 years.
  • 3.Patients with no wall defect (occlusal caries with intact proximal wall) and one wall defect either MO or DO (occlusal caries with involving proximal wall) diagnosed with irreversible pulpitis in mandibular first and second molars.
  • 4.Mature teeth with closed apices.
  • 5.Patients with class I occlusion with intact adjacent and opposing teeth.
  • 6.Patients categorized under ASA (American Society of Anesthesiologists) 1 and 2.

排除标准

  • Patients categorized under ASA (American Society of Anesthesiologists) 3 and
  • 2.Poor oral hygiene with periodontal diseases and gingival index score more than
  • 3.Patients with non-vital teeth with periapical abscess 4.Patients with fractured teeth, obliterated canals, root resorption and retreatment cases.
  • 5.Buccal and Lingual wall defect and wall thickness less than 2mm.
  • 6.Presence of any para functional habits, wasting disease and maligned teeth.
  • 7.Patients having TMJ problem.
  • 8.Immature teeth with open apex.

结局指标

主要结局

To provide proper marginal adaptation, restoration integrity and prevent tooth fracture.

时间窗: 5 minutes

次要结局

  • It increases the longevity of the post endodontic restoration(2 years)

研究者

发起方
Self
申办方类型
Research institution and hospital

研究点 (1)

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