- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07693946
Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations
Jaw Tracking Impact on Occlusion and Patient Outcomes in Maxillary Implant Restorations: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shahira s Mohamed, BDS
- Phone Number: +20 1004455178
- Email: shahirasaad@mans.edu.eg
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt
- Recruiting
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Workflow
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.
|
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.
|
|
Experimental: Digital Jaw-Tracking Workflow
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At prosthesis insertion, 3 months, and 6 months after prosthesis insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occlusal Accuracy
Time Frame: At prosthesis insertion and 3 months after insertion
|
Occlusal accuracy will be evaluated using the OccluSense digital occlusal analysis system by assessing the distribution and stability of occlusal contact points.
|
At prosthesis insertion and 3 months after insertion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shahira S Mohamed, BDS, Faculty of Dentistry, Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS.25.12.99
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Edentulism
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Mansoura UniversityCompletedPartial Edentulism | Partial Edentulism Class 1Egypt
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Al-Azhar UniversityRecruitingEdentulism | Edentulism in Lower JawEgypt
-
Dentsply Sirona Implants and ConsumablesCompletedPartial Edentulism | Edentulism NosSweden
-
Universidad Complutense de MadridRecruiting
-
Dentsply Sirona ImplantsCompletedEdentulismGermany, United States, Italy
-
Elite OdontoiatricaActive, not recruiting
-
University of Alabama at BirminghamACE Surgical Supply, Inc.Completed
-
Najla ChebibNot yet recruitingEdentulism | Edentulism Complete
Clinical Trials on Conventional Prosthetic Workflow
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...CompletedDental Prosthesis ComplicationItaly
-
VA Office of Research and DevelopmentRecruitingTransfemoral Amputation | Limb Loss | Limb AbsenceUnited States
-
Tanta UniversityCompletedDentures | Digital | Mandibular DimensionsEgypt
-
Gerardo F Fasce Pineda, MDActive, not recruitingElderly | Functional Status | Dental Restoration | Removable Dental ProsthesisChile
-
VA Office of Research and DevelopmentUniversity of TexasCompletedDiabetes Complications | AmputationUnited States
-
VA Office of Research and DevelopmentRecruitingTranstibial Amputation | Transfemoral AmputationUnited States
-
Superior UniversityActive, not recruiting
-
Stanford UniversitySociety of Thoracic RadiologyWithdrawn
-
University Hospital, Basel, SwitzerlandCompletedPartial-edentulism | Implant-supported Fixed Dental Prostheses (iFDP)Switzerland
-
Concordia Dent SrlCarol Davila University of Medicine and Pharmacy; MINECCompletedPartially Edentulous Maxilla | Partially Edentulous MandibleRomania