CClinicalTrials.gg
Not yet recruitingNCT07657910QuasiUpdated Jun 18, 2026

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

An interventional study of After and Before in Partially Edentulous Mandible, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Partially Edentulous Mandible

Keywords

  • Kennedy Class II
  • mandible
  • Bite optimization
  • implant
  • 3shape
  • Artificial intelligence
  • Occlusal contact
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureAfter

    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.

  • ProcedureBefore

    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.

06

What researchers measure

Primary outcomes

  1. Occlusal contact distribution

    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.

    Time frame: From enrollment till the end of the study 17 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07657910
Lead sponsor
Cairo University
Responsible party
Noha Waleed Fathalla Moustafa Barakat (Dr, Cairo University) — Principal investigator
First posted
Jun 18, 2026
Start date
Jun 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 18, 2026

Study contacts

Noha Walid Barakat, Masters degree
Contact
noha.barakat@dentistry.cu.edu.eg
+201149902334 ext. 002
Ahmed Mustafa Kotb, Lecturer
Contact
ahmed.kotb@dentistry.cu.edu.eg
01006697790 ext. 002

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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