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临床试验/CTRI/2026/01/100408
CTRI/2026/01/100408尚未招募不适用

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

Department of Prosthodontics ESIC Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月18日最近更新:

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

发起方
Department of Prosthodontics ESIC Dental College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Divakar S

ESIC Dental College and Hospital

研究点 (1)

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