Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change from Baseline in Oral health related quality of life at 90 days after denture relining
研究概览
简要总结
Purpose: the aim of the present study was to analyze the impact of mandibular denture relining with soft or hard denture liners in the oral health related quality of life (OHRQoL) of edentulous patients.
The null hypothesis was that there would be no difference in OHRQoL findings after mandibular denture relining between patient groups treated with hard or soft denture liners.
详细描述
Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22) or a hard acrylic resin based denture liner (Kooliner; Group 2; control n=22) with chairside procedures. The OHIP EDENT (Oral Health Impact profile) questionnaire was given to patients prior to reline procedures (baseline-T0) and 90 days (T90) post relining. Three possible answers and scores were proposed for each question: never (0), sometimes (1) and almost always (2). Results were analyzed by means of the generalized linear model (p≤0.05) considering two factors: time (T0 and T90) and group (hard and soft denture liners).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Edentulous in both jaws
- •Complete denture wearers
- •Clinically acceptable occlusal relationships
- •Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.
排除标准
- •Residual vertical bone height of 10 mm or less
- •No attached mucosa in any region of mandible (type E)
- •Dentures with deteriorated intaglio surfaces
- •Dentures with large pre-existing fractures
- •Dentures with severely altered occlusal vertical dimension
- •Extremely worn artificial teeth
- •Dentures with unsatisfactory occlusions
- •Neurological diseases
- •Lack of motor coordination
- •Difficulty of understanding instructions and the conditions of the study
- •Patients with residual roots, cysts or bone spicules
- •Patients with allergies to methyl methacrylate or silicone
- •Knife-edge mandibular ridges.
结局指标
主要结局
Change from Baseline in Oral health related quality of life at 90 days after denture relining
时间窗: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.
The Oral Health Related Quality of Life (OHRQoL) was assessed through the application of the questionnaire OHIP EDENT at baseline and 90 days post denture relining. Four domains developed for the Brazilian OHIP-EDENT9 were used: (D1) 'masticatory-related complaints, (D2) 'psychological discomfort and disability', (D3) 'social disability' and (D4) 'oral pain and discomfort'. The questionnaires were carried out via interviews by one individual examiner , who was blinded for the denture liner. The interviews lasted approximately ten minutes.Three possible answers to questions one to nineteen with their scores in parenthesis were given as options: never (0), sometimes (1) or almost always (2).
次要结局
未报告次要终点
研究者
Marina Xavier Pisani
Dds, MsC, PhD
Fundação de Amparo à Pesquisa do Estado de São Paulo