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临床试验/CTRI/2024/06/068622
CTRI/2024/06/068622尚未招募2 期

Comparative evaluation of marginal fit, periodontal response and clinical performance of teeth restored with 3D printed and CAD CAM milled composite crowns -A randomized controlled clinical study

Dr Sayam Shah1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
Marginal fit periodontal response and clinical performance

研究概览

简要总结

Fixed dental prostheses  are widely used to replace missing teeth. A crucial factor for their success is a good marginal fit, which prevents issues like micro-leakage and gum problems.

With advancements, dentists now have various materials for fixed partial denture. This study aims to compare 3D-printed resin crowns with milled composite crowns. While milled crowns have limitations, 3D printing offers better control and precision.

There’s no existing data on the clinical performance of 3D-printed permanent fixed partial denture. This study will evaluate how well 3D-printed resins compare to milled composite crowns in terms of marginal fit, gum health, and overall performance over a year.

The hypothesis is that 3D-printed resins may lead to better clinical outcomes due to potentially superior marginal fit.

The study will compare 3D-printed resin crowns with milled composite crowns for single tooth restoration.

Steps include:

  1. Screening patients and obtaining consent.

  2. Randomly assigning patients to either group (3D-printed or milled crowns).

  3. Preparing the teeth for crowns.

  4. Taking digital impressions and designing crowns.

  5. Fabricating crowns (3D-printed or milled).

  6. Evaluating marginal fit of the crowns.

  7. Cementing the crowns.

  8. Monitoring patients’ gums and plaque buildup for 1 year.

  9. Evaluating the clinical performance of the crowns for 1 year.

  10. Analyzing the data.

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
21.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Participants requiring at least two crowns in maxillary or mandibular permanent posterior teeth with following indications 1 Teeth restored with large filling restorations.
  • 2 Endodontically treated teeth.
  • 3 Malformed teeth 4 Occlusal function with a natural tooth 5 No tooth mobility 6 Teeth with sound gingival and periodontal health 7 Psychologically and physically able to co-operate during the tooth preparation procedure.
  • 8 Ability and willingness of patient to come for required appointments.

排除标准

  • 1 Patients in growth stage with partially erupted teeth 2 Patients with medical history in which any dental intervention would be contraindicated 3 Patients with any local or systemic disease or condition or medication that might compromise health of the periodontium 4 Patient with clinical sign or history of bruxism 5 Patients who use tobacco in any form.

结局指标

主要结局

Marginal fit periodontal response and clinical performance

时间窗: At baseline,3 months and six months.

次要结局

未报告次要终点

研究者

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

Dr Sayam Shah

k m shah dental college

研究点 (1)

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