A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Denture Satisfaction
研究概览
简要总结
The objective of this study is to compare the canine guidance (CG) and bilateral balanced occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.
详细描述
Reference for published version of the complete study:
Paleari AG, Marra J, Rodriguez LS, De Souza RF, Pero AC, De A Mollo Jr F, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures.J Oral Rehabil. 2012 Apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. [Epub ahead of print]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients needing new complete dentures
- •Mentally receptiveness
- •Absence of dysfunctional disorders of the masticatory system
- •Normal volume and resilience of residual edentulous ridges
- •Absence of debilitating systemic diseases
排除标准
- •Use of cardiac pacemaker
- •Refusal to participate or inability to provide informed consent
结局指标
主要结局
Denture Satisfaction
时间窗: 30 days
Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).
次要结局
- Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis(30 days)
- Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis(30 days)
- Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis(30 days)
- Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis(30 days)
- Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis(30 days)
- Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis(30 days)
- Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis(30 days)
- Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis(30 days)
- Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis(30 days)
- Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis(30 days)
- Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis(30 days)
- Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis(30 days)
研究者
Raphael Freitas de Souza
Assistant Professor
University of Sao Paulo