跳至主要内容
临床试验/CTRI/2025/10/096535
CTRI/2025/10/096535尚未招募不适用

Bite Force and Muscle Activity in Two- vs. Three-Implant Mandibular Overdentures (TIMOD): A Comparative Study

Faculty of Dental Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月15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
20
试验地点
1
主要终点
To investigate the differences in masticatory muscle activity and force distribution between two-implant and three-implant-supported mandibular over dentures opposing maxillary complete denture.

研究概览

简要总结

Edentulism, the complete loss of teeth, affects over 30% of the global population, particularly the elderly, leading to impaired mastication, decreased muscle activity, and reduced quality of life. Conventional complete dentures, though widely used, often provide inadequate stability and retention—especially in the mandibular arch—resulting in patient discomfort and inefficient chewing. Implant-supported overdentures have emerged as a superior alternative, offering improved support, retention, stability, and bone preservation, while enhancing aesthetics and psychological well-being. The McGill Consensus (2002) and New York Consensus (2009) endorse mandibular implant-supported overdentures as the standard of care for edentulous patients. Two-implant overdentures significantly enhance masticatory efficiency and muscle coordination, whereas three-implant overdentures further improve prosthesis stability, reduce screw loosening, and minimize crestal bone loss. This study aims to compare masticatory muscle activity and bite force distribution between two- and three-implant-supported mandibular overdentures using electromyography (EMG) and bite force assessments. Following fabrication of conventional dentures, baseline EMG, bite force, and chewing efficiency will be recorded, followed by implant placement and subsequent evaluations at 1, 3, and 6 months. The findings will provide insight into how implant number influences muscle performance, bite dynamics, and functional efficiency in edentulous patients.

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
40.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Edentulous maxilla and mandibles with adequate bone volume requiring implant-supported mandibular over-dentures opposing conventional maxillary complete denture(as confirmed by CBCT/3D imaging) Good general health without contraindications for implant surgery Willing to report for follow-up visits.
  • No acute infection.
  • Informed and signed consent.

排除标准

  • Patients with history of A)Tobacco intake (smoke or smokeless) or any other substance abuse.
  • B)Temporomandibular disorders.
  • C)Irradiation in the head and neck region.
  • Patients with para functional habits (bruxism or clenching) 2)Pregnant patients.
  • Active chemotherapy or active radiotherapy.

结局指标

主要结局

To investigate the differences in masticatory muscle activity and force distribution between two-implant and three-implant-supported mandibular over dentures opposing maxillary complete denture.

时间窗: AT 1,3 AND 6 MONTH

次要结局

  • This study will evaluate and compare muscle activity, bite force distribution and chewing efficiency between(1) conventional complete denture and two implant supported mandibular over denture)

研究者

发起方
Faculty of Dental Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sayani Podder

Faculty of Dental Sciences, BHU

研究点 (1)

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