Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study (Quasi)

June 14, 2026 updated by: Noha Waleed Fathalla Moustafa Barakat, Cairo University
The aim of the study is to evaluate the occlusal contact distribution in digitally fabricated implant-retained fixed partial dentures in mandibular Kennedy Class II patients before and after artificial intelligence bite optimization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning. Two implants will be placed in the edentulous span in all participants. All surgical steps will be held according to standard protocol. After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments. After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken. Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow. The data acquisition will take place by scanning the patients using Medit intraoral scanner. Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run. It automatically recalculates the position of the bite relation using its integrated AI. After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients with a unilateral mandibular distal extension area (Kennedy Class II partially edentulous mandibular arch) and who are indicated for the insertion of 2 implants.
  2. Fully dentate opposing maxillary arch or restored with a suitable, well constructed fixed prosthesis.
  3. The remaining teeth should be in good periodontal health, with no signs of inflammation or movement.
  4. The edentulous area should be covered by a healthy, firm mucoperiosteum, with no or minimal tissue undercut.
  5. Patient should be with class I occlusion.
  6. No occlusal disorder; stable jaw relation.
  7. No TMD signs or symptoms.
  8. Patients should be in generally good health and free of systemic conditions that can affect the implant treatment, such as diabetes mellitus.

Exclusion Criteria:

  1. Patients with psychological or mental disorders.
  2. Patients with insufficient interarch space.
  3. Patients with parafunctional habits, such as bruxism.
  4. After the healing phase and exactly before the prosthetic phase, if the inserted implants showed any signs of peri-implantitis or aggressive crestal bone resorption, then this case will be excluded and replaced with another case.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Before
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning. Two implants will be placed in the edentulous span in all participants. All surgical steps will be held according to standard protocol. After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments. After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken. Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
Procedure: Before
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning. Two implants will be placed in the edentulous span in all participants. All surgical steps will be held according to standard protocol. After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments. After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken. Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
Active Comparator: After
The data acquisition will take place by scanning the patients using Medit intraoral scanner. Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run. It automatically recalculates the position of the bite relation using its integrated AI. After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.
Procedure: After
The data acquisition will take place by scanning the patients using Medit intraoral scanner. Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run. It automatically recalculates the position of the bite relation using its integrated AI. After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occlusal contact distribution
Time Frame: From enrollment till the end of the study 17 weeks

The 1ry outcome will be assessed on the day of the prosthesis delivery. First, the reading of the occlusal contact distribution will be taken by using the T-scan device before seating the prosthesis intraorally.

Then, the retained fixed prosthesis will be seated on the implant abutment, and the prosthetic screw will be screwed to the optimum torque. Another reading of the occlusal contact distribution will be taken by using the T-scan device after seating and torquing the prosthesis intraorally. Finally, the screw access channels will be closed by flowable resin composite material.
From enrollment till the end of the study 17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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