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Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures

2026年9月19日 更新者：Dr. Fatima Shakeel、Watim Medical & Dental College

Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study

This randomized controlled trial compares two final impression techniques for complete dentures, the open mouth technique and the closed mouth technique. Completely edentulous adults with well-formed ridges will be randomly assigned 1:1 to one of the two techniques. All dentures will be made by a single operator using the same materials and laboratory. Six weeks after insertion, an examiner blinded to group allocation will assess denture retention using the Kapur index, and patient satisfaction will be recorded using a 5-item Likert questionnaire.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

In the open mouth group, border molding and the wash impression are made with the patient's mouth open and no occlusal contact. In the closed mouth group, occlusal rims are attached to the custom trays at a predetermined occlusal vertical dimension, and the impression is made while the patient closes and performs functional movements. Jaw relations, try-in, and insertion follow the same protocol for both groups. Retention is scored separately for the maxillary and mandibular dentures, with a score of 2 or 3 counted as adequate. Satisfaction scores range from 5 to 25, and a score of 16 or above counts as satisfied.

研究类型

介入性

注册 (估计的)

88

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 巴基斯坦
    • Punjab Province
      • Rawalpindi、Punjab Province、巴基斯坦、46000
        • Department of Prosthodontics, Watim Medical and Dental College, Rawat, Rawalpindi, Punjab, Pakistan
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 18 to 70 years
  • Completely edentulous in both maxilla and mandible for at least six months, confirmed by clinical examination and orthopantomogram
  • Well-formed ridges, ACP classification Class I or Class II

Exclusion Criteria:

  • Flabby or hypermobile ridges
  • Atrophic ridges
  • Ridges with bony exostosis
  • Active oral pathology
  • History of radiotherapy to head and neck
  • Uncontrolled systemic disease
  • Neuromuscular or neurological disorders

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Group A: Open Mouth Technique

Final impressions made in custom trays with sectional border molding using low fusing impression compound and a zinc oxide eugenol wash, with the mouth open and no occlusal contact.
程序：Open mouth impression technique

Secondary impression of the edentulous arch made in a custom acrylic tray. Border molding is done in sections with low fusing impression compound, followed by a zinc oxide eugenol wash impression. The clinician manipulates the tissues and the patient performs functional movements, with the mouth open and no occlusal contact. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.

其他名称：
  • Open mouth functional impression
  • Conventional border molded impression
有源比较器：Group B: Closed Mouth Technique

Final impressions made in custom trays with attached occlusal rims set to a predetermined vertical dimension. Border molding and the wash impression are made while the patient closes into occlusion and performs functional movements.
程序：Closed mouth impression technique

Secondary impression made in custom trays with occlusal rims attached and adjusted to a predetermined occlusal vertical dimension. Maxillary and mandibular trays are inserted together. Border molding with low fusing impression compound and a zinc oxide eugenol wash impression are made while the patient closes into occlusion and performs functional movements, recording the denture bearing areas under simulated functional load. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.

其他名称：
  • Closed mouth functional impression
  • Functional impression under occlusal loading

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adequate retention of maxillary denture
大体时间：6 weeks after denture insertion

Kapur index score (0 nil, 1 poor, 2 fair, 3 good) assessed by a blinded examiner. A score of 2 or 3 is adequate and 0 or 1 is inadequate.
6 weeks after denture insertion

次要结果测量

结果测量
措施说明
大体时间
Adequate retention of mandibular denture
大体时间：6 weeks after denture insertion

Kapur index score assessed the same way as the maxillary denture.
6 weeks after denture insertion
Patient satisfaction
大体时间：6 weeks after denture insertion

5-item Likert questionnaire covering retention, comfort, mastication, phonetics, and overall satisfaction, with a total score of 5 to 25. A score of 16 or above counts as satisfied.
6 weeks after denture insertion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Watim Medical & Dental College

调查人员

  • 首席研究员：Fatima Shakeel, BDS、Watim Medical and Dental College
  • 研究主任：Zarah Afreen, BDS, FCPS、Watim Medical and Dental College

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年9月15日

首先提交符合 QC 标准的

2026年9月15日

首次发布 (实际的)

2026年9月21日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月19日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • WMDC/R&D(ERB)/2025/241

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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