- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06862973
Digital Analysis of Occlusal Force Distribution in Single-Tooth Implant Restorations
Comparison of Occlusal Force Distribution and Digital Occlusal Analysis Methods of Single Posterior Implant Restorations and Digital Occlusal Analysis Methods
This study will explore the impact of single tooth implant restorations upon occlusal force distribution and the accuracy of several digital analysis methods. The biomechanical behavior of implant-supported prostheses differs from that of natural teeth, and the distribution and modulation of occlusal forces are unpredictable.
The research used the Medit i700 intraoral scanner and the OccluSense system to take pre- and post-implant measurements. The research aims to determine: How are the techniques different in the registration of occlusal contacts and force magnitude? and How does occlusal balance shift following the placement of an implant? The research findings can be used to provide clinical recommendations to optimize occlusal balancing during implant prosthetics.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Meram
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Konya, Meram, Turkey, 42090
- Konya Necmettin Erbakan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals aged 18 and over
- Patients with good periodontal health
- Patients with a Class I bite
- Patients with a single tooth deficiency in the posterior region planned for rehabilitation with an implant-supported single crown restoration
Exclusion Criteria:
- History of temporomandibular joint disease
- Acute pain or signs of occlusal dysfunction
- Restricted mouth opening
- Absence of a tooth distal to the planned restoration
- Occlusion instability due to prior orthodontic or surgical treatments
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Occlusal Force Distribution from Pre-Implant to Post-Implant Restoration as Measured by Medit i700 and OccluSense
Time Frame: From pre-implant assessment to 2 week after final implant restoration placement.
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Occlusal force distribution was measured before and after single-tooth implant restoration using two digital occlusal analysis methods: Medit i700 intraoral scanner and OccluSense pressure sensor system.
Measurements were taken under standardized conditions, ensuring maximum intercuspation position.
Medit i700 provided contact area data through intraoral scans, analyzed with CloudCompare software, while OccluSense recorded occlusal force intensity and distribution, analyzed with ImageJ software.
The percentage change in occlusal contact areas and force distribution was calculated between the pre- and post-implant conditions.
A statistically significant change (p < 0.05) indicates an alteration in occlusal balance following the restoration.
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From pre-implant assessment to 2 week after final implant restoration placement.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20754
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- CSR
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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