NCT07693946

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Dec 2025Jan 2027

Study Start

First participant enrolled

December 25, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2027

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

EdentulismComplete Maxillary Edentulism

Keywords

Digital jaw trackingMaxillary implant-supported prosthesisScrew-retained prosthesisOcclusal accuracyPatient satisfactionOccluSenseRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    At prosthesis insertion, 3 months, and 6 months after prosthesis insertion

Secondary Outcomes (1)

  • Occlusal Accuracy

    At prosthesis insertion and 3 months after insertion

Study Arms (2)

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.

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.

Procedure: Digital Jaw-Tracking Workflow

Interventions

Conventional Prosthetic WorkflowPROCEDURE

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.

Conventional Workflow
Digital Jaw-Tracking WorkflowPROCEDURE

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.

Digital Jaw-Tracking Workflow

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Shahira S Mohamed, BDS

    Faculty of Dentistry, Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahira s Mohamed, BDS

CONTACT

+20 1004455178shahirasaad@mans.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: a conventional workflow group or a digital jaw-tracking workflow group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical demonstrator at prosthodontics department

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

December 25, 2025

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

January 25, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

There is no current plan to share individual participant data. Participant confidentiality will be maintained according to institutional ethical requirements.

Locations

EG(1)