Resorption of MandibleNCT06562972
3D Assessment of Mandibular Bone Loss Via STL Superimposition After Complete Denture Occlusal Adjustment
A study testing Occlusal equilibration of complete denture using articulating paper and Occlusal equilibration of complete denture using occulosense in people with Resorption of Mandible, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Resorption of Mandible
- What is being tested?
- Occlusal equilibration of complete denture using articulating paper and Occlusal equilibration of complete denture using occulosense
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Aug 2024to 18 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
- Patient's with neuromuscular disorders
Show all 9Show fewer
- Patients on chemotherapy or radiotherapy
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Quantification Assessment of Mandibular Bone Resorption Using STL Registration-Based Superimposition Following Removable Complete Denture Occlusal Equilibration
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.
Read the 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.
- Conditions
- Resorption of Mandible
- Being tested
- Occlusal equilibration of complete denture using articulating paper, Occlusal equilibration of complete denture using occulosense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal equilibration of complete denture using articulating paperOther
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 occulosenseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Occlusal equilibration of complete denture using occulosense |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, thee months, six months and twelve months
Secondary outcomes (1)
Patient Satisfaction
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)
Measured: Baseline, thee months, six months and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start18 Aug 2024
- Primary completion18 Aug 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resorption of MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady El Naggar, Badr University
- Investigators
- Shady Elnaggar, Principal investigator, Badr university in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562972
- Sponsor's protocol ID
- 2024-2
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Quantification Assessment of Mandibular Bone Resorption Using STL Registration-Based Superimposition Following Removable Complete Denture Occlusal Equilibration
- ClinicalTrials.gov ID
- NCT06562972
- Acronym / sponsor ID
- 2024-2
- Conditions
- Resorption of Mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusal equilibration using articulating paper | Active comparator | Other: Occlusal equilibration of complete denture using articulating paperThe 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. |
| Occlusal equilibration using Occulosense | Experimental | Other: Occlusal equilibration of complete denture using occulosenseThe 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Temporomandibular disorders
- Uncontrolled diabetes
- Bleeding disorders or anticoagulant therapy
- Flabby tissues or sharp mandibular residual ridge.
- Heavy smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal equilibration of complete denture using articulating paperOcclusal 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. | Other | Occlusal equilibration using articulating paper |
| Occlusal equilibration of complete denture using occulosenseOcculosense 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. | Other | Occlusal equilibration using Occulosense |
Primary outcome
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.
1 secondary outcome
Patient Satisfaction
Time frame: Baseline, thee months, six months and twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shady Elnaggar principal investigator
Badr university in Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal equilibration of complete denture using articulating paper and Occlusal equilibration of complete denture using occulosense in people with Resorption of Mandible, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D Quantification Assessment of Mandibular Bone Resorption (time frame: Baseline, thee months, six months and twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.