跳至主要内容
临床试验/CTRI/2022/03/041319
CTRI/2022/03/041319尚未招募不适用

Clinical Performance of Reinforced Glass Ionomer Materials in Class-II Restorations - A 12 Month Randomized Controlled Clinical Trial

Dr Amit Kumar1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Equia Forte HT and Zirconomer Improved may prove to be an effective substitute for amalgam in restoring deep Class-II cavities present in stress bearing areas.

研究概览

简要总结

The aim of the study is to evaluate the clinical performance of two modified glass ionomers i.e glass hybrid restorative materials in comparison with a nanocomposite material in deep Class-II cavities using Modified USPHS criteria. . Seventy-five patients diagnosed with reversible pulpits(CLass-II carious lesions) in posterior teeth will be randomly divided into three groups: Group A- EQUIA FORTE HT, Group B- ZIRCONOMER IMPROVED and Group C- FILTEK Z350XT UNIVERSAL. All the patients will be subjected to Class-II cavity preparation followed by restoration. After the treatment, patients from each group would be recalled after one week (baseline), 3 months, 6 months, 12 months from the day of restoration to evaluate the restorations made using given different materialsusing MODIFIED USPHS CRITERIA under which following parameters would be evaluated:1. Color Match 2. Marginal Discoloration 3. Anatomic Form 4. Contact Point 5. Marginal Adaptation 6. Retention 7. Secondary Caries 8. Surface Texture 9. Post-operative Sensitivity. The data obtained, will be subjected to statistical analysis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria: 1) Patients in the age group of 18-50 years.
  • Presence of adjacent and antagonist teeth.
  • Asymptomatic and vital teeth.
  • One or more proximal carious lesions in the posterior teeth.
  • A healthy periodontal status (absence of tooth mobility and absence of bleeding on probing) 6) Likelihood of recall availability.

排除标准

  • Exclusion Criteria: 1) Partially erupted teeth 2) Unhealthy periodontal status 3) Absence of adjacent and antagonist teeth.
  • Carious lesion <3mm depth.
  • Carious pulpal exposure 6) Past and fractured restorations 7) Patients suffering from xerostomia 8) Pregnant women.

结局指标

主要结局

Equia Forte HT and Zirconomer Improved may prove to be an effective substitute for amalgam in restoring deep Class-II cavities present in stress bearing areas.

时间窗: Post restoration: | 1 week (baseline) | 3 months | 6 months | 12 months

次要结局

  • Clinical performance of each restorative material would be evaluated on the basis of following parameters:(1. Color Match)

研究者

发起方
Dr Amit Kumar
申办方类型
Other [self]

研究点 (1)

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