EdentulismNCT07693946
Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations
A study testing Conventional Prosthetic Workflow and Digital Jaw-Tracking Workflow in people with Edentulism and Complete Maxillary Edentulism, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to evaluate the effect of integrating digital jaw tracking into the workflow for fabrication of full-arch maxillary implant-supported screw-retained restorations. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Edentulism, Complete Maxillary Edentulism
- What is being tested?
- Conventional Prosthetic Workflow and Digital Jaw-Tracking Workflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2025to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 50 to 70 years.
- Completely edentulous maxillary arch opposing natural mandibular dentition.
- Skeletal Class I maxillomandibular relationship with normal occlusion.
- Acceptable oral hygiene.
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Systemic diseases affecting bone healing, such as uncontrolled diabetes mellitus or osteoporosis.
- Harmful oral habits, including smoking, clenching, or bruxism.
- Uncooperative patients or patients unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations: Randomized Clinical Trial
This randomized clinical trial aims to evaluate the effect of integrating digital jaw tracking into the workflow for fabrication of full-arch maxillary implant-supported screw-retained restorations. Twenty completely edentulous maxillary patients opposing natural mandibular dentition will be randomly assigned to either a conventional workflow group or a digital jaw-tracking workflow group. The study will compare patient satisfaction and occlusal accuracy between the two groups. Patient satisfaction will be assessed using a visual analogue scale (VAS), while occlusal accuracy will be evaluated using the OccluSense system.
Read the detailed description
This randomized clinical trial will compare conventional prosthetic workflow with a digital jaw-tracking workflow for the fabrication of full-arch maxillary implant-supported screw-retained restorations.
Twenty edentulous patients with completely edentulous maxillary arches opposing natural mandibular dentition will be recruited and randomly allocated into two equal groups. Group A will receive restorations fabricated using the conventional workflow with static jaw relation records, while Group B will receive restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator.
The primary outcome will be patient satisfaction, assessed using a visual analogue scale (VAS) after prosthesis insertion and during follow-up visits. Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system. The study aims to determine whether digital jaw tracking improves occlusal accuracy and patient-reported outcomes compared with the conventional workflow.
- Conditions
- Edentulism, Complete Maxillary Edentulism
- Being tested
- Conventional Prosthetic Workflow, Digital Jaw-Tracking Workflow
- Keywords
- Digital jaw tracking, Maxillary implant-supported prosthesis, Screw-retained prosthesis, Occlusal accuracy, Patient satisfaction, OccluSense, Randomized clinical trial
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Prosthetic WorkflowProcedure or surgery
Fabrication of a full-arch maxillary implant-supported screw-retained prosthesis using conventional jaw relation records, a facebow or average-value articulator, and conventional occlusal adjustment procedures.
Digital Jaw-Tracking WorkflowProcedure or surgery
Fabrication of a full-arch maxillary implant-supported screw-retained prosthesis using a digital workflow with dynamic jaw tracking, virtual articulator integration, and CAD/CAM technology for patient-specific occlusal design.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Workflow | Active comparator | Participants will receive full-arch maxillary implant-supported screw-retained restorations fabricated using the conventional workflow with conventional jaw relation records and standard occlusal adjustment procedures. Receives: Procedure: Conventional Prosthetic Workflow |
| Digital Jaw-Tracking Workflow | Experimental | Participants will receive full-arch maxillary implant-supported screw-retained restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator for patient-specific occlusal design. Receives: Procedure: Digital Jaw-Tracking Workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction will be assessed using a Visual Analogue Scale (VAS) to evaluate patient satisfaction with the implant-supported prosthesis regarding comfort, chewing ability, aesthetics, and phonetics.
Measured: At prosthesis insertion, 3 months, and 6 months after prosthesis insertion
Secondary outcomes (1)
Occlusal Accuracy
Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system by assessing the distribution and stability of occlusal contact points.
Measured: At prosthesis insertion and 3 months after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start25 Dec 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of two parallel groups: a conventional workflow group or a digital jaw-tracking workflow group.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahira Saad Abd ElKhabeer Mohamed Elsyed Ali, Mansoura University
- Investigators
- Shahira S Mohamed, BDS, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693946
- Sponsor's protocol ID
- MS.25.12.99
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data. Participant confidentiality will be maintained according to institutional ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07693946
- Acronym / sponsor ID
- MS.25.12.99
- Conditions
- Edentulism, Complete Maxillary Edentulism
- Keywords
- Digital jaw tracking, Maxillary implant-supported prosthesis, Screw-retained prosthesis, Occlusal accuracy, Patient satisfaction, OccluSense, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (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.
This randomized clinical trial aims to evaluate the effect of integrating digital jaw tracking into the workflow for fabrication of full-arch maxillary implant-supported screw-retained restorations. Twenty completely edentulous maxillary patients opposing natural mandibular dentition will be randomly assigned to either a conventional workflow group or a digital jaw-tracking workflow group. The study will compare patient satisfaction and occlusal accuracy between the two groups. Patient satisfaction will be assessed using a visual analogue scale (VAS), while occlusal accuracy will be evaluated using the OccluSense system.
Detailed description
This randomized clinical trial will compare conventional prosthetic workflow with a digital jaw-tracking workflow for the fabrication of full-arch maxillary implant-supported screw-retained restorations.
Twenty edentulous patients with completely edentulous maxillary arches opposing natural mandibular dentition will be recruited and randomly allocated into two equal groups. Group A will receive restorations fabricated using the conventional workflow with static jaw relation records, while Group B will receive restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator.
The primary outcome will be patient satisfaction, assessed using a visual analogue scale (VAS) after prosthesis insertion and during follow-up visits. Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system. The study aims to determine whether digital jaw tracking improves occlusal accuracy and patient-reported outcomes compared with the conventional workflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a conventional workflow group or a digital jaw-tracking workflow group.
| Arm | Type | Receives |
|---|---|---|
| Conventional Workflow | Active comparator | Procedure: Conventional Prosthetic WorkflowParticipants will receive full-arch maxillary implant-supported screw-retained restorations fabricated using the conventional workflow with conventional jaw relation records and standard occlusal adjustment procedures. |
| Digital Jaw-Tracking Workflow | Experimental | Procedure: Digital Jaw-Tracking WorkflowParticipants will receive full-arch maxillary implant-supported screw-retained restorations fabricated using a digital workflow incorporating dynamic jaw tracking and a virtual articulator for patient-specific occlusal design. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 50 to 70 years.
- Completely edentulous maxillary arch opposing natural mandibular dentition.
- Skeletal Class I maxillomandibular relationship with normal occlusion.
- Acceptable oral hygiene.
- Willing and able to provide written informed consent and comply with study procedures.
Key exclusion criteria (3 listed)
- Systemic diseases affecting bone healing, such as uncontrolled diabetes mellitus or osteoporosis.
- Harmful oral habits, including smoking, clenching, or bruxism.
- Uncooperative patients or patients unable to comply with study procedures.
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 |
|---|---|---|
| Conventional Prosthetic WorkflowFabrication of a full-arch maxillary implant-supported screw-retained prosthesis using conventional jaw relation records, a facebow or average-value articulator, and conventional occlusal adjustment procedures. | Procedure or surgery | Conventional Workflow |
| Digital Jaw-Tracking WorkflowFabrication of a full-arch maxillary implant-supported screw-retained prosthesis using a digital workflow with dynamic jaw tracking, virtual articulator integration, and CAD/CAM technology for patient-specific occlusal design. | Procedure or surgery | Digital Jaw-Tracking Workflow |
Primary outcome
Patient Satisfaction
Time frame: At prosthesis insertion, 3 months, and 6 months after prosthesis insertion
Patient satisfaction will be assessed using a Visual Analogue Scale (VAS) to evaluate patient satisfaction with the implant-supported prosthesis regarding comfort, chewing ability, aesthetics, and phonetics.
1 secondary outcome
Occlusal Accuracy
Time frame: At prosthesis insertion and 3 months after insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data. Participant confidentiality will be maintained according to institutional ethical requirements.
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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.
Shahira S Mohamed, BDS principal investigator
Faculty of Dentistry, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Prosthetic Workflow and Digital Jaw-Tracking Workflow in people with Edentulism and Complete Maxillary Edentulism, run by Mansoura 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 3 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shahira s Mohamed, BDS (+20 1004455178, shahirasaad@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: At prosthesis insertion, 3 months, and 6 months after prosthesis insertion). 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 9 Jul 2026.