- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06562972
3D Assessment of Mandibular Bone Loss Via STL Superimposition After Complete Denture Occlusal Adjustment
3D Quantification Assessment of Mandibular Bone Resorption Using STL Registration-Based Superimposition Following Removable Complete Denture Occlusal Equilibration
Study Overview
Status
Conditions
Detailed Description
STL registration-based superimposition is an innovative technique for evaluating mandibular bone resorption in patients using removable complete dentures (RCDs). This 3D method aligns and compares digital mandible models from different time points, providing precise volumetric and surface change measurements. The process involves 3D scanning, STL file conversion, model registration, superimposition, and quantification.
Occlusal equilibration of RCDs is crucial for distributing masticatory forces evenly, influencing bone resorption patterns. Research using this technique has shown that mandibular bone resorption is non-uniform, with variations across different mandibular regions.
While offering superior accuracy and comprehensive analysis compared to traditional methods, this approach faces challenges such as potential registration errors and the need for specialized equipment and expertise. Future developments may incorporate machine learning, biomechanical modeling, and longitudinal studies to enhance understanding and clinical application in prosthodontics and oral surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Badr University in Cairo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Completely edentulous patients ranging from age 45 to 75 years
- Angle's Class I skeletal relationship
- Normal facial symmetry
- Cooperative patients
- Adequate inter-arch space not less than 12mm
Exclusion Criteria
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
- Patient's with neuromuscular disorders
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Occlusal equilibration using articulating paper
The articulating paper method is a widely used technique for occlusal equilibration of complete dentures.
The process begins by seating the dentures properly and using thin articulating paper to mark occlusal contacts as the patient lightly bites down.
High spots are identified by darker or larger marks and are carefully reduced with a fine diamond or acrylic bur.
The process is repeated until even contact is achieved across all teeth.
The method also involves checking occlusion during different jaw movements and making necessary adjustments.
Finally, the adjusted areas are polished, and the patient's comfort is assessed.
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Occlusal equilibration of complete dentures is vital for ensuring proper function, comfort, and longevity.
The process aims to evenly distribute occlusal forces, eliminate premature contacts, improve stability, reduce wear, and minimize tissue trauma.
It involves methods like the articulating paper technique, pressure indicator paste, T-Scan digital analysis, and clinical observation.
The process includes evaluating centric and eccentric contacts, making fine adjustments, and achieving balanced articulation.
Regular follow-ups are essential to monitor occlusion and make necessary adjustments, contributing to patient satisfaction and denture lifespan.
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Experimental: Occlusal equilibration using Occulosense
The Oculosense system, is an advanced tool in dentistry for analyzing occlusion, especially in denture equilibration.
It includes an ultra-thin sensor and software that records and displays the force and timing of occlusal contacts in real-time.
This system provides detailed data on force distribution, contact timing, and the center of force, offering 2D and 3D visualizations.
It allows for precise, dynamic adjustments of dentures by identifying high-pressure areas and premature contacts.
Despite its benefits, including high precision and quantifiable data, it is costlier and requires specialized training.
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Occulosense denture equilibration is a digital occlusal analysis technique used to optimize denture fit and function.
It employs a thin sensor placed between the dentures to measure bite force and timing.
The system provides real-time data on occlusal contacts, allowing dentists to identify and adjust pressure points precisely.
This process ensures even distribution of bite forces, enhancing denture stability, comfort, and longevity.
T-Scan equilibration can significantly improve patient satisfaction by reducing pain, increasing chewing efficiency, and minimizing denture-related issues like sore spots and uneven wear.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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3D Quantification Assessment of Mandibular Bone Resorption
Time Frame: Baseline, thee months, six months and twelve months
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3D quantification assessment of mandibular bone resorption uses advanced imaging techniques like Cone Beam Computed Tomography (CBCT) and digital 3D software to measure and analyze bone loss in the lower jaw.
This process is essential for accurate diagnosis, treatment planning (e.g., implants), and monitoring bone changes over time.
It provides precise measurements, visual representations, and comprehensive analysis of bone density and volume, aiding in better clinical outcomes.
Despite its advantages, it can be costly and involves radiation exposure, making it less accessible in some practices.
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Baseline, thee months, six months and twelve months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Satisfaction
Time Frame: Baseline, thee months, six months and twelve months
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The Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) containing 19 questions were obtained from each of the seven conceptual domains of the OHIP (functional limitation, physical pain, psychologic discomfort, physical disability, psychologic disability, social disability, and handicap)
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Baseline, thee months, six months and twelve months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shady Elnaggar, Badr University in Cairo
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
- 2024-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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