NCT06377475

Brief Summary

The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

March 18, 2024

Last Update Submit

April 17, 2024

Conditions

Keywords

BruxismJaw RelationshipImpression Technic

Outcome Measures

Primary Outcomes (1)

  • Wax vs JIG Registration

    The deviation (in micrometers) between the wax and JIG registration will be measured with the software CloudCompare.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (1)

  • Questionnaire

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Wax registration

The jaw relation for the Michigan-splint will be performed with wax.

Procedure: Jaw relationProcedure: Questionnaire

JIG registration

The jaw relation for the Michigan-splint will be performed with JIG.

Procedure: Jaw relationProcedure: Questionnaire

Interventions

Jaw relationPROCEDURE

The quality of the Michigan-splint will be analyzed according to different interventions (wax or jig jaw relation) and a questionnaire that quantify the occlusal contacts of the splint.

JIG registrationWax registration
QuestionnairePROCEDURE

The quality of the Michigan-splint will be analyzed according to different interventions (wax or jig jaw relation) and a questionnaire that quantify the occlusal contacts of the splint.

JIG registrationWax registration

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll genders are eligible to participate in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dental Students

You may qualify if:

  • Dental students in the first year of their Master\'s degree
  • years and older, gender independent
  • Ability to give informed consent, documented by signature

You may not qualify if:

  • Inability or contraindications (e.g. dental pain, dental mobility, generalized periodontitis, removable denture wearers, acute infection) to undergo the procedure under study
  • Inability to follow the procedures of the study, e.g. due to language problems, depression or mental disorders
  • Students who do not consent to the analysis of the data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZB

Basel, 4058, Switzerland

Location

MeSH Terms

Conditions

Bruxism

Interventions

Jaw Relation RecordSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

DentistryData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. med. dent.

Study Record Dates

First Submitted

March 18, 2024

First Posted

April 22, 2024

Study Start

March 8, 2024

Primary Completion

May 1, 2024

Study Completion

December 1, 2025

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations