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临床试验/CTRI/2025/10/096531
CTRI/2025/10/096531尚未招募不适用

Ultrasonographic and Electromyographic assessment of muscle characteristics post rehabilitation with complete denture and implant (UEMC): A prospective study

Faculty of dental sciences ims bhu2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年11月16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
12
试验地点
2
主要终点
1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6

研究概览

简要总结

This study aims to evaluate changes in masseter and temporalis muscle thickness and electrical activity in completely edentulous patients rehabilitated with complete dentures and implant-supported prostheses using ultrasonography and electromyography. Complete edentulism reduces muscle thickness and impairs mastication, whereas implant prostheses provide superior support, enhancing bite force, chewing efficiency, and neuromuscular activity. Although literature supports these benefits, comprehensive comparisons between dentures and implants remain limited. The present prospective in vivo study will include twelve patients assessed at baseline, three months, and six months post-rehabilitation. Statistical analysis will compare outcomes to determine the relative effectiveness of dentures and implants in restoring muscle characteristics.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy.
  • Non-smokers.
  • Edentulous individuals who were at least 1 months and a maximum 6 months edentulism.
  • Edentulous individuals who have never used prosthesis before.
  • No contraindications to implant placement.

排除标准

  • Patients with history of any chronic illness (any systemic disease) Tobacco intake (smoke or smokeless) or any other substance abuse.
  • Temporomandibular disorders.
  • History of undergoing surgical procedures involving facial muscles or muscles of mastication.
  • Irradiation in the head and neck area.
  • Patients with poor oral hygiene.
  • Pregnant patients.
  • Active chemotherapy or active radiotherapy.

结局指标

主要结局

1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6

时间窗: 1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6 months | 2. To assess changes in muscle electrical activity in completely edentulous patients rehabilitated with complete dentures and implants using electromyography(EMG) 13 weeks and 26 weeks

months

时间窗: 1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6 months | 2. To assess changes in muscle electrical activity in completely edentulous patients rehabilitated with complete dentures and implants using electromyography(EMG) 13 weeks and 26 weeks

2. To assess changes in muscle electrical activity in completely edentulous patients rehabilitated with complete dentures and implants using electromyography(EMG) after 13 weeks and 26 months

时间窗: 1. To assess changes in muscle thickness in completely edentulous patients rehabilitated with complete dentures and implants using ultrasonography (USG) after 3 months and 6 months | 2. To assess changes in muscle electrical activity in completely edentulous patients rehabilitated with complete dentures and implants using electromyography(EMG) 13 weeks and 26 weeks

次要结局

未报告次要终点

研究者

发起方
Faculty of dental sciences ims bhu
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Krishan Kant Sharma

Faculty of Dental Sciences, IMS BHU

研究点 (2)

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