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

NCT06562972 | Completed

• 1 other identifier: 2024-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resorption of Mandible

Outcome Measures

Primary Outcomes (1)

• 3D Quantification Assessment of Mandibular Bone Resorption

  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.

  Baseline, thee months, six months and twelve months

Secondary Outcomes (1)

• Patient Satisfaction

  Baseline, thee months, six months and twelve months

Study Arms (2)

Occlusal equilibration using articulating paper

ACTIVE COMPARATOR

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.

Other: Occlusal equilibration of complete denture using articulating paper

Occlusal equilibration using Occulosense

EXPERIMENTAL

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.

Other: Occlusal equilibration of complete denture using occulosense

Interventions

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 using articulating paper

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.

Occlusal equilibration using Occulosense

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Female patients were excluded in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Badr university in Cairo

Cairo, Egypt

Location

Study Officials

• Shady Elnaggar

  Badr university in Cairo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: August 18, 2024
• Primary Completion: August 18, 2025
• Study Completion: September 18, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)