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Completed

NCT Number: NCT06562972

3D Assessment of Mandibular Bone Loss Via STL Superimposition After Complete Denture Occlusal Adjustment

STL registration-based superimposition is an advanced technique for assessing mandibular bone resorption in removable complete denture (RCD) patients. This 3D method involves aligning and comparing digital models of the mandible before and after RCD use, offering high accuracy and comprehensive analysis. The process includes 3D scanning, STL conversion, registration, superimposition, and quantification. Occlusal equilibration of RCDs plays a crucial role in distributing masticatory forces and influencing bone resorption patterns. Studies using this technique have revealed non-uniform resorption, with variations in different regions of the mandible. While offering numerous advantages over traditional methods, challenges include potential registration errors and the need for specialized equipment and expertise. Future developments may incorporate machine learning, biomechanical modeling, and long-term studies to enhance understanding and clinical application of this technology in prosthodontics and oral surgery.

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Key information

Conditions

Resorption of Mandible

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Badr university in Cairo

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occlusal equilibration of complete denture using articulating paper

Other

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.

Occlusal equilibration of complete denture using occulosense

Other

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.

Primary outcomes

  1. 3D Quantification Assessment of Mandibular Bone Resorption

    Time frame: Baseline, thee months, six months and twelve months

    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.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: Baseline, thee months, six months and twelve months

    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)

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

3D Quantification Assessment of Mandibular Bone Resorption Using STL Registration-Based Superimposition Following Removable Complete Denture Occlusal Equilibration

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.