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临床试验/CTRI/2023/05/053220
CTRI/2023/05/053220已完成1/2 期

Evaluation of Functional and Esthetic outcomes of Removable Complete Dentures fabricated with CAD/CAM technology- A Cross-over Randomized Controlled Clinical Trial

Priyasha R. Wase1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年6月22日最近更新:
适应症

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.

研究概览

简要总结

EVALUATION OF FUNCTIONAL AND ESTHETIC OUTCOMES OF REMOVABLE COMPLETE DENTURES FABRICATED WITH CAD-CAM TECHNOLOGY****A CROSS OVER RANDOMISED CONTROLLED CLINICAL TRIAL

The introduction and evolution of computer-aided technology in the field of CD fabrication has considerably reduced the time spent in fabrication and they claim with the availability of the necessary armamentarium dentures can be fabricated in a single day. The objectives of this study is to compare between CAD-CAM Baltic denture system and bilateral balanced complete denture prostheses, by Blinded evaluation of retention and stability using functional assessment of denture- FAD Questionnaire. Blinded evaluation of aesthetics using Frush and Fisher Aesthetics criteria. Self -Evaluation of Patient’s satisfaction and comfort by means of a Denture Satisfaction Questionnaire. Assessment of Patients quality of life (OHRQoL) before and after treatment by means of   Oral Health Impact Profile Questionnaire (OHIP’19). 8 completely edentulous patients with Class I ridge relationship will be selected through convenient sampling. 2 sets of complete dentures – One CAD-CAM Baltic denture system and One conventionally fabricated complete denture will be fabricated for each patient. Once the dentures are fabricated randomization will be done for the type of denture which the patient will be given first. Patients will be BLINDED for the type of denture which is given to them

研究设计

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

入排标准

年龄范围
45.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •Completely edentulous patients with class I ridge relation, Class I and II ridge morphology (PDI) Adult patients needing new complete dentures Mentally receptiveness Patients able to understand the informed consent Patient who are able to come for 9-10 visits.
  • •Absence of dysfunctional disorders of the masticatory system Absence of debilitating systemic diseases.

排除标准

  • •Refusal to participate in the study.
  • •Patients with class II and class III ridge relation.
  • •Patients with past history of Complete dentures Symptoms of Temporomandibular disorders Patients with severe xerostomia Patients with parafunctional habits Patients with severe oral manifestations of systemic disease Psychologic or psychiatric conditions that could influence response to treatment.
  • •Patient asking for implant supported/retained prostheses.

结局指标

主要结局

Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.

时间窗: 2 months

次要结局

  • Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.(1 month)

研究者

发起方
Priyasha R. Wase
申办方类型
Other [Self sponsored]

研究点 (1)

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