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临床试验/CTRI/2020/03/024165
CTRI/2020/03/024165尚未招募不适用

EVALUATION OF FUNCTIONAL AND ESTHETIC OUTCOMES OF CAD-CAM BALTIC DENTURE AND CONVENTIONAL DENTURE REMOVABLE PROSTHESES - A CROSS OVER RANDOMISED CLINICAL TRIAL

B T Pradeep Raja1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
8
试验地点
1
主要终点
3.Patient satisfaction

研究概览

简要总结

Conventionalmethod of fabricating Complete Dentures [CD] has been in practice since 1860’s . Bilateral Balanced articulation have been proposed as one of the functionallyadvantageous Denture System in terms of stability, even distribution of forcesand denture comfort . Conventional Complete Dentures and Denturesconstructed with Bilateral balanced Articulation has the additional advantageof predictable aesthetics, as individualised teeth arrangement is possibleincluding characterisation of pink and white aesthetics. Through the years, thecontinuing goal was to overcome all the drawbacks associated with the processof fabrication, and enhancements of the properties of materials used fordenture base and teeth. No significant changes were noted in theimpression making and jaw relation procedures involved with conventionalcomplete denture fabrication. Theintroduction and evolution of computer-aided technology in the field of CDfabrication has considerably reduced the time spent in fabrication and theyclaim with the availability of the necessary armamentarium dentures can befabricated in a single day . The first scientific paper on theuse of a computer-aided system for designing and fabricating CDs was publishedby Maeda et al., in 1994, and these dentures were made by additive RapidPrototyping [RP] technology, from photo-polymerised acrylate material using a3-dimensional Laser Lithographic (LL) machine. It took almost 20years for the emergence of the first commercially available denture systems. Very fewstudies and reports are available on the outcome evaluation of the newlyintroduced Baltic system . The advantage of time and simplicity ofthe procedure have attracted the clinicians and have urged them to cater to thedemanding patients overlooking the cost which is involved in the process.With thementioned advantages and disadvantages of the two systems, it is planned toconduct a clinical trial to study the functional and aesthetic outcomes of thepatient with conventional complete denture system with bilateral balancedarticulation and Baltic denture system.

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
50.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • •1.Completely edentulous patients with class I ridge relation, Class I &II ridge morphology (PDI).
  • •2.Adult patients needing new complete dentures 3.Mentally receptiveness 4.Patients able to understand the informed consent 5.Patient who are able to come for 9-10 visits.
  • •6.Absence of dysfunctional disorders of the masticatory system 7.Absence of debilitating systemic diseases.

排除标准

  • •1.Refusal to participate in the study.
  • •2.Patients with class II and class III ridge relation.
  • •3.Patients with past history of Complete dentures 4.Symptoms of Temporomandibular disorders 5.Patients with severe xerostomia 6.Patients with parafunctional habits 7.Patients with severe oral manifestations of systemic disease 8.Psychologic or psychiatric conditions that could influence response to treatment.
  • •9.Patient asking for implant supported/retained prostheses.

结局指标

主要结局

3.Patient satisfaction

时间窗: After one month of each intervention

1.Functional outcomes - Blinded evaluation of retention and stability using functional assessment of denture - FAD questionnaire

时间窗: After one month of each intervention

2.Aesthetic outcomes - blinded evaluation of aesthetics using Frush and Fisher Aesthetics criteria

时间窗: After one month of each intervention

4.Comfort- self evaluation of patients satisfaction and comfort by means of a denture satisfaction questionnaire

时间窗: After one month of each intervention

次要结局

  • PATIENT QUALITY OF LIFE assessment of patients quality of life (OHRQoL) before and after treatment by means of Oral Health Impact Profile Questionnaire (OHIP19)(AFTER ONE MONTH OF EACH INTERVENTION)

研究者

发起方
B T Pradeep Raja
申办方类型
Other [self]

研究点 (1)

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