- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06581614
Masticatory Performance Evaluation (MPE)
Effect of Implant Supported Fixed Restoration on Masticatory Efficiency in Patients With Second Molar Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chewing is one of the important steps in the process of food digestion, and it is crucial for human nutritional intake and oral health. Chewing efficiency relates to the ability to eat and is influenced by many factors, with the key factor being the absence of posterior teeth. According to traditional occlusal theory, the anterior teeth guide and act as a facade, while the posterior teeth provide support and chewing function. The loss of posterior teeth leads to a decrease in chewing efficiency. In 1954, Dr. A. Albert Yurkstas and others proposed that in healthy adults, the loss of the first molar results in a 33% decrease in chewing efficiency; the loss of the second and third molars results in a 44% decrease; and the loss of the first, second, and third molars results in a 78% decrease. This study laid the foundation for understanding how tooth loss leads to decreased chewing efficiency and highlights the goal of prosthodontics to restore dental arches and chewing function to benefit people.
The purpose of this experiment is to combine the study of chewing efficiency with the expertise of prosthodontics in reconstruction, aiming to investigate the impact of contemporary gold-standard artificial implant-supported fixed restorations on chewing efficiency. The study invites patients missing the second molar and those receiving implant-supported fixed prostheses reconstruction in the Department of Prosthodontics at National Taiwan University Hospital. The new and simpler color-changeable chewing gum will be used to test their chewing efficiency. This will explore the importance of implant-supported fixed prostheses in reconstructing chewing function after the loss of the second molar, aiming to improve patient well-being and understanding of dental implants by restoring chewing function through clinical implant reconstruction. In the research field, this study provides guidance for the reconstruction strategies of chewing function
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yi-Hao Lan, DDS, MS
- Phone Number: +886 922901103
- Email: blue-mac@hotmail.com
Study Locations
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-
-
Taipei, Taiwan
- Not yet recruiting
- National Taiwan University Hospital
-
Contact:
- Phone Number: 262508 +886 02 23123456
- Email: fctsai@ntu.edu.tw
-
Taipei, Taiwan
- Recruiting
- Yi-Hao Lan
-
Contact:
- Yi-Hao Lan
- Phone Number: 262508 +886 02 23123456
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
For prospective group:
Inclusion Criteria:
- Patients who have lost their second molar, are scheduled to undergo single-implant reconstruction at the Prosthodontics Department of National Taiwan University Hospital, and do not have any major physical or mental health conditions.
Exclusion Criteria:
- Severe temporomandibular joint disorder
- Inability to comply with the treatment schedule
- Inability to cooperate with masticatory function tests
- Lack of opposing teeth for the implant-supported restoration
- Patients whose anterior teeth will be included in the prosthetic reconstruction or whose occlusion will undergo significant changes after reconstruction
For retrospective group:
Inclusion Criteria:
- Patients who have lost their second molar, have undergone single-implant-supported fixed restoration reconstruction at the Prosthodontics Department of National Taiwan University Hospital, and do not have any major physical or mental health conditions.
Exclusion Criteria:
- Implant-supported dentures that cannot be removed or have significant damage
- Severe temporomandibular joint disorder
- Inability to comply with the treatment schedule
- Inability to cooperate with masticatory function tests
- Lack of opposing teeth for the implant-supported denture
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
prospective group
Patients who have lost their second molar, are scheduled to undergo single-implant reconstruction at the Prosthodontics Department of National Taiwan University Hospital, and do not have any major physical or mental health conditions
|
During the test, participants will be given a piece of chewing gum to assess their masticatory function when the second molar implant-supported fixed denture is in place.
|
|
retrospective group
Patients who have lost their second molar, have undergone single-implant-supported fixed restoration reconstruction at the Prosthodontics Department of National Taiwan University Hospital, and do not have any major physical or mental health conditions.
|
During the test, participants will be given a piece of chewing gum to assess their masticatory function when the second molar implant-supported fixed denture is in place.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the masticatory performance of patients
Time Frame: After second molar implant reconstruction was done(at least 1 month after reconstruction)
|
During the test, participants will be given a piece of chewing gum to assess their masticatory function when the second molar implant-supported fixed restoration is in place.
|
After second molar implant reconstruction was done(at least 1 month after reconstruction)
|
Collaborators and Investigators
Investigators
- Study Director: Yi-Hao Lan, National Taiwan University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202407119RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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