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临床试验/CTRI/2025/11/098190
CTRI/2025/11/098190尚未招募4 期

Comparison of accelerated and simplified dentures with conventional dentures in patients with total edentulism: Randomized trial to assess denture quality, quality of life, and nutrition

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Geriatric Oral Health Assessment Index (Hindi)

研究概览

简要总结

This study aims to address this gap by evaluating an accelerated, simplified complete denture (ASCD) protocol. The aim is to reduce the overall time of rehabilitation. The economical use of materials shall help to curtail the cost of treatment as well. These strategies will attempt to maximize quality quantity by recommending an efficient and less complex procedure particularly when on a constraint budget.The reduction in number of appointments is also accompanied by economical use of materials and use of materials that enable to use the technique in a wide spectrum of clinical conditions (Prosthodontic diagnostic index I to IV).The study shall help to determine whether the alternate ASCD technique helps to generate clinically acceptable dentures (denture quality), meets the oral health related quality of life (GOHAI-H), and attain a satisfactory nutritional status (NRI)in accordance with the CCD therapy. 80 participants will be enrolled as per inclusion and exclusion criteria. Study Area : Hospital Division of Prosthodontics, Centre for Dental Education and Research, AIIMS New Delhi and Lab Medicine, AIIMS New DelhiThe participants will be completely edentulous individuals between the age of 55 to 80 years.  Period of edentulism will be not less than 6 months. Participants enrolled will be 1st time denture wearers. Participants providing written informed consent will be included in the study.Exclusion criteria will consist of presence of temporomandibular disorders, insufficient mouth opening, presence of systemic illnesses compromising nutritional status such as liver disorders, renal disorders, cancer, endocrinal disorders, gastrointestinal disorders, metabolic disorders, and presence of psychiatric disorders. Completely edentulous participants (as per inclusion and exclusion criteria)  who will be treated by conventional complete denture fabrication technique will be included as controls.  Study design is Concurrent parallel arm   Duration of follow up is 12months. At time of denture placement and 12 months after placement the following investigations will be done: GOHAI (H), Nutritional risk Index (albumin, height, and weight will be required), and denture quality by using Woelfel’s index.

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
55.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • The participants will be completely edentulous individuals between the age of 55 to 80 years.
  • Period of edentulism will be not less than 6 months.
  • Participants enrolled will be 1st time denture wearers.
  • Participants providing written informed consent will be included in the study.

排除标准

  • will consist of presence of temporomandibular disorders, insufficient mouth opening, presence of systemic illnesses compromising nutritional status such as liver disorders, renal disorders, cancer, endocrinal disorders, gastrointestinal disorders, metabolic disorders, and presence of psychiatric disorders.

结局指标

主要结局

Geriatric Oral Health Assessment Index (Hindi)

时间窗: 1 week after insertion , 12 months after insertion

次要结局

  • Nutritional Risk Index (NRI)(At denture placement and 12 months after denture placement)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Aditi Nanda

AIIMS, New Delhi

研究点 (1)

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