Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Adequate retention of maxillary denture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The six-week retention assessment is done by an independent examiner blinded to group allocation, and the questionnaire is given by a person not involved in denture fabrication. The operator and the participants are not blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Open mouth impression technique (Procedure)
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.
干预措施: Closed mouth impression technique (Procedure)
结局指标
主要结局
Adequate retention of maxillary denture
时间窗: 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.
次要结局
- Adequate retention of mandibular denture(6 weeks after denture insertion)
- Patient satisfaction(6 weeks after denture insertion)
研究者
Dr. Fatima Shakeel
Postgraduate Resident, Department of Prosthodontics
Watim Medical & Dental College