Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges
试验速览
- 阶段
- 3 期
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Oral health related quality of life
研究概览
简要总结
BACKGROUND: The literature has shown that simplified methods for complete denture fabrication can be as effective as the traditional techniques, but with less expenditure of time and resources, without prejudice to the patients. However, the effectiveness of these simplified methods for patients with more complex medical conditions haven't been deeply explored.
OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete dentures fabrication for patients with severely resorbed mandibular alveolar bones.
METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a university clinic will be rehabilitated following a simplified technical proposal, being divided randomly into two groups according to the mandibular arch molding technique. In group A, a single impression with alginate through pre-fabricated trays will be performed, while patients allocated in group B will receive a second molding with a more complex technique. After 3 and 6 months, besides important clinical parameters, it will be investigated aspects related to patient's perceptions about the success of treatment. The study will be conducted with a minimum of 30 participants per group, and comparisons between the two groups will be made by means of tests suitable for distribution of data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •complete edentulism for at least one year;
- •desire to receive a pair of new conventional complete dentures
- •mental receptiveness;
- •good understanding of spoken Portuguese
排除标准
- •disorders of the masticatory system;
- •pathological changes of residual ridges;
- •debilitating systemic diseases.
研究组 & 干预措施
Simplified protocol
The application of a simplified denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps:
- Obtainment of maxillary and mandibular casts by using irreversible hydrocolloid in stainless steel stock trays for record bases fabrication.
- Adjustment of record bases according to vertical dimension and centric relation measurements, with no use of facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected.
- Trial dentures will be evaluated for esthetics and maxillomandibular relationship.
- Insertion of finished dentures.
干预措施: Denture fabrication technique (Procedure)
Traditional protocol
The importance of a second impression for denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps:
- Maxillary and mandibular casts obtained by using irreversible hydrocolloid in stainless steel stock trays for maxillary record base and mandibular custom tray fabrication.
- Mandibular second impression with border molding using compound and impression rubber in custom tray.
- Record bases adjustments without facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected.
- Trial dentures will be evaluated for esthetics and maxillomandibular relationship.
- Finished dentures insertion.
结局指标
主要结局
Oral health related quality of life
时间窗: 6 months
This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory
次要结局
- Satisfaction with dentures (assessed by means of two specific questionaries)(6 months)
- Denture quality (assessed by means of a clinical examination according to a specific form)(3 months)
- Masticatory performance (assessed by means of a colorimetric method based on an artificial test food)(6 months)
研究者
Romulo Rocha Regis
Prof. Dr. Rômulo Rocha Regis
Universidade Federal do Ceara