- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280130
Evaluation of Occlusal Adjustment Material Removal on Monolithic Zirconia Blocks: An In Vitro Study
This study aims to improve understanding of the amount of tooth-replacement material removed during a single grinding "stroke" performed in the adjustment of a zirconia crown. Zirconia is a highly durable ceramic material commonly used for dental restorations, and accurate adjustment is essential for achieving proper occlusion. However, existing literature does not provide quantitative data regarding material removal per stroke during chairside adjustment, resulting in reliance on individual clinical experience.
In this study, standardized zirconia specimens will be prepared and assigned to three operator groups: dental students, dental interns, and experienced clinicians. Each participant will perform a controlled number of grinding strokes on the specimens using a commonly used dental grinding stone. Specimens will be scanned before and after grinding using a three-dimensional scanner to precisely quantify material removal.
Hypothesis
The hypotheses of this study are:
Each grinding stroke results in a measurable and relatively consistent amount of zirconia material removal.
Experienced clinicians demonstrate more controlled and predictable material removal per stroke compared with students and interns.
Study Overview
Status
Intervention / Treatment
Detailed Description
Clinical occlusal adjustment requires precision within tens of micrometers; however, current literature lacks objective data regarding per-stroke material removal during chairside adjustment of monolithic zirconia. As a result, clinical decision-making largely depends on subjective judgment.
Objective
The objective of this study is to quantify material removal per single reciprocating grinding stroke on monolithic zirconia blocks using a silicon carbide grinding stone and to compare performance among operators with different levels of clinical experience.
Methods
Monolithic zirconia specimens (VITA YZ ST; dimensions: 8 × 2 × 15 mm) will be milled, sintered, and embedded into standardized holders. Operators will include 40 fourth-year dental students, 40 sixth-year dental interns, and 40 experienced clinicians. Each participant will perform 100 grinding strokes along an 8-mm linear path at a frequency of 100 strokes per minute, guided by a metronome.
Grinding will be performed using a silicon carbide stone (Dura-Green Stone HP 0031/PC2, SHOFU, Japan) operated at 20,000 rpm. Pre- and post-grinding scans will be obtained using a 3Shape F8 scanner. Scan datasets will be superimposed using feature-based alignment to calculate volumetric loss and thickness reduction, expressed as mm³ per stroke and µm per stroke, respectively.
Statistical Analysis
Mixed-effects models will be applied to evaluate group-by-stroke interactions. Reference intervals for material removal will be established, and results will be translated into a clinically applicable occlusal adjustment guide.
Expected Results
The study is expected to define the magnitude and variability of zirconia material removal per grinding stroke, identify differences in performance between operator experience levels, and highlight areas requiring targeted educational training.
Conclusion
This in vitro investigation will provide the first stroke-level quantitative evidence for monolithic zirconia occlusal adjustment. The findings are expected to enhance the accuracy of clinical decision-making, improve training assessment, and support evidence-based guidelines for zirconia crown adjustment.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yihao Lan, DDS, MSD
- Phone Number: 0922901103
- Email: blue-mac@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consists of 120 participants from three levels of dental training and early clinical practice, recruited from a dental school and affiliated clinical institutions. The sample includes:
- Fourth-year dental students
- Sixth-year dental interns
- Clinicians with 0-5 years of post-graduation experience
Participants are generally healthy adults capable of performing fine motor tasks required for dental procedures. Exclusion criteria include acute hand/upper-limb injuries, neuromuscular disorders, uncorrected poor vision, and inability to follow a metronome rhythm.
Description
Inclusion Criteria:
Group A: Forty fourth-year dental students who have completed preclinical courses in operative dentistry, complete denture prosthodontics, and fixed prosthodontics (Part I). They have little to no experience in adjusting zirconia.
Group B: Forty sixth-year dental interns. Each participant will be tested twice-once before and once near the end of their clinical training. A questionnaire will also record their prosthodontic clinical experience within the past year.
Group C: Forty licensed clinicians with 0-5 years of post-graduation experience (with practical experience in zirconia adjustment). A questionnaire will also document their clinical experience in prosthodontics.
Exclusion Criteria:
- Acute upper-limb/hand injuries or postoperative recovery within the past 3 months that may affect grip strength or fine motor control.
- Neuromuscular disorders or tremor/postural control impairments (e.g., essential tremor, peripheral neuropathy, moderate to severe carpal tunnel syndrome) that prevent stable operation.
- Uncorrected or inadequately corrected vision that does not meet the requirements for close-range tasks (e.g., inability to clearly see fine markings at a distance of 30-40 cm even with correction).
- Inability to follow the metronome rhythm (100 beats per minute).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
A.fourth-year dental students
Forty fourth-year dental students who have completed preclinical courses in operative dentistry, complete denture prosthodontics, and fixed prosthodontics (Part I).
They have little to no experience in adjusting zirconia.
|
Each participant will perform 100 strokes along an 8-mm path at a rate of 100 strokes per minute, guided by a metronome on the monolithic zirconia
|
|
B.sixth-year interns
Forty sixth-year dental interns.
Each participant will be tested twice-once before and once near the end of their clinical training.
A questionnaire will also record their prosthodontic clinical experience within the past year.
|
Each participant will perform 100 strokes along an 8-mm path at a rate of 100 strokes per minute, guided by a metronome on the monolithic zirconia
|
|
C.clinicians
Forty licensed clinicians with 0-5 years of post-graduation experience (with practical experience in zirconia adjustment).
A questionnaire will also document their clinical experience in prosthodontics.
|
Each participant will perform 100 strokes along an 8-mm path at a rate of 100 strokes per minute, guided by a metronome on the monolithic zirconia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The amount of material removal per stroke
Time Frame: about 12 months
|
Amount of Zirconia Material Removed per Grinding Stroke(um/stroke)
|
about 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Material Removal Rate Between Grinding Phases
Time Frame: approximately 12 months
|
Difference in mean zirconia material removal per stroke between early grinding phase (strokes 1-50) and late grinding phase (strokes 51-100) Unit of Measure: μm/stroke (difference between phases) |
approximately 12 months
|
|
Percentile Distribution of Zirconia Material Removal by Operator Experience Level
Time Frame: approximately 12 months
|
Percentile distribution (e.g., 25th, 50th, 75th percentiles) of zirconia material removal per grinding stroke within each operator experience group Unit of Measure: percentile values |
approximately 12 months
|
Collaborators and Investigators
Investigators
- Study Director: Yihao Lan, DDS, MSD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202510051RINA
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
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