Masticatory PerformanceMPENCT06581614
Masticatory Performance Evaluation
An observational study of Masticatory Performance, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
The purpose of this experiment is to combine research on masticatory efficiency with the reconstructive expertise of the prosthodontics clinic, focusing on implant-supported fixed dentures as the contemporary gold standard for reconstruction. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Masticatory Performance
- What is being tested?
- masticatory function test
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 31 Aug 2024to 31 Aug 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have lost their second molar
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
National Taiwan University Hospital
Taipei
+886 02 23123456 ext. 262508, fctsai@ntu.edu.tw
- Recruiting
Yi-Hao Lan
Taipei
Yi-Hao Lan, +886 02 23123456 ext. 262508
About this study
Official title: Effect of Implant Supported Fixed Restoration on Masticatory Efficiency in Patients With Second Molar Loss
The purpose of this experiment is to combine research on masticatory efficiency with the reconstructive expertise of the prosthodontics clinic, focusing on implant-supported fixed dentures as the contemporary gold standard for reconstruction. The goal is to investigate the impact of such prosthetic reconstructions on masticatory efficiency. We will invite patients who have lost their second molar and have undergone single-implant-supported fixed denture reconstruction at the Prosthodontics Department of National Taiwan University Hospital to participate in masticatory function tests. The tests will use a new and relatively simple chewing gum, with the aim of enhancing patients\' masticatory function through implant reconstruction in a clinical setting, thereby improving patient well-being and understanding of dental implants. On the research side, the study aims to provide guidance for strategies in the reconstruction of masticatory function.
Read the 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
- Conditions
- Masticatory Performance
- Being tested
- masticatory function test
- Keywords
- implant supported fixed prosthesis, masticatory efficiency, chewing gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
masticatory function testDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: masticatory function test | |
| 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. Receives: Diagnostic Test: masticatory function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the masticatory performance of patients
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.
Measured: After second molar implant reconstruction was done(at least 1 month after reconstruction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start31 Aug 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Masticatory PerformanceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hao Lan, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581614
- Sponsor's protocol ID
- 202407119RINA
- Acronym
- MPE
- Status last verified
- Oct 2025
- First submitted
- 30 Aug 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the privacy of patients
Publications
Tarkowska A, Katzer L, Ahlers MO. Assessment of masticatory performance by means of a color-changeable chewing gum. J Prosthodont Res. 2017 Jan;61(1):9-19. doi: 10.1016/j.jpor.2016.04.004. Epub 2016 May 17.
PubMed 27211494
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implant Supported Fixed Restoration on Masticatory Efficiency in Patients With Second Molar Loss
- ClinicalTrials.gov ID
- NCT06581614
- Acronym / sponsor ID
- MPE / 202407119RINA
- Conditions
- Masticatory Performance
- Keywords
- implant supported fixed prosthesis, masticatory efficiency, chewing gum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this experiment is to combine research on masticatory efficiency with the reconstructive expertise of the prosthodontics clinic, focusing on implant-supported fixed dentures as the contemporary gold standard for reconstruction. The goal is to investigate the impact of such prosthetic reconstructions on masticatory efficiency. We will invite patients who have lost their second molar and have undergone single-implant-supported fixed denture reconstruction at the Prosthodontics Department of National Taiwan University Hospital to participate in masticatory function tests. The tests will use a new and relatively simple chewing gum, with the aim of enhancing patients\' masticatory function through implant reconstruction in a clinical setting, thereby improving patient well-being and understanding of dental implants. On the research side, the study aims to provide guidance for strategies in the reconstruction of masticatory function.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective group | – | Diagnostic Test: masticatory function testPatients 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 |
| retrospective group | – | Diagnostic Test: masticatory function testPatients 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. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have lost their second molar
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| masticatory function testDuring 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. | Diagnostic test | prospective group, retrospective group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 27211494Tarkowska A, Katzer L, Ahlers MO. Assessment of masticatory performance by means of a color-changeable chewing gum. J Prosthodont Res. 2017 Jan;61(1):9-19. doi: 10.1016/j.jpor.2016.04.004. Epub 2016 May 17.
- Individual participant dataSharing planned: No. For the privacy of patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Hao Lan study director
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Masticatory Performance, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Hao Lan, DDS, MS (+886 922901103, blue-mac@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the masticatory performance of patients (time frame: After second molar implant reconstruction was done(at least 1 month after reconstruction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.