Assessment of long-term patient satisfaction of complete dentures fabricated using simplified and conventional complete dentures on oral health impact profile for edentulous patients (OHIP-EDENT): A randomized double-blinded crossover clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This randomized, double-blinded, two-period crossover clinical trial aims to compare patient satisfaction and oral health–related quality of life in completely edentulous patients rehabilitated with simplified and conventional complete dentures. The simplified technique uses a chairside visible light-cured resin protocol to fabricate a custom tray and occlusal rims in fewer clinical visits, while the conventional technique follows the traditional multi-visit denture fabrication protocol.
Participants are randomly allocated to one of two treatment sequences and receive both types of complete dentures during two study periods. Outcome assessments are performed only after 3 months (end of Period 1) and 6 months (end of Period 2) following denture insertion. Patient-reported outcomes are evaluated using the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) and a 100-mm Visual Analogue Scale (VAS). The study aims to determine whether simplified complete dentures provide comparable patient satisfaction and oral health–related quality of life when compared with conventional dentures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Completely edentulous maxillary and mandibular arches Previous complete denture wearers Severly resorbed mandibular ridge Possessing an adequate understanding of written and spoken Hindi/Kannada/English.
- •Able to understand and respond to the questionnaire used in the study.
排除标准
- •Acute/chronic symptoms of temporomandibular disorders Uncontrolled systemic diseases Any oral pathology requiring intervention Psychological conditions that could influence the patient’s reaction to the treatment Flabby residual ridges Smokers and tobacco users Patients wanting dental implants.
研究者
Divakar S
ESIC Dental College and Hospital
