NCT06581614

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2024Aug 2027

First Submitted

Initial submission to the registry

August 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

November 18, 2025

Status Verified

October 1, 2025

Enrollment Period

2.4 years

First QC Date

August 30, 2024

Last Update Submit

November 16, 2025

Conditions

Keywords

implant supported fixed prosthesismasticatory efficiencychewing gum

Outcome Measures

Primary Outcomes (1)

  • 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.

    After second molar implant reconstruction was done(at least 1 month after reconstruction)

Study Arms (2)

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

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.

Diagnostic Test: masticatory function test

Interventions

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.

prospective groupretrospective group

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have lost their second molar

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan

NOT YET RECRUITING

Yi-Hao Lan

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Yi-Hao Lan

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Yi-Hao Lan, DDS, MS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 3, 2024

Study Start

August 31, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

November 18, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

For the privacy of patients

Locations