NCT07657910

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Jun 2026Sep 2026

Study Start

First participant enrolled

June 1, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 14, 2026

Last Update Submit

June 14, 2026

Conditions

Keywords

Kennedy Class IImandibleBite optimizationimplant3shapeArtificial intelligenceOcclusal contact

Outcome Measures

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.

    From enrollment till the end of the study 17 weeks

Study Arms (2)

Before

EXPERIMENTAL

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

After

ACTIVE COMPARATOR

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

AfterPROCEDURE

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.

After
BeforePROCEDURE

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.

Before

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Fully dentate opposing maxillary arch or restored with a suitable, well constructed fixed prosthesis.
  • The remaining teeth should be in good periodontal health, with no signs of inflammation or movement.
  • The edentulous area should be covered by a healthy, firm mucoperiosteum, with no or minimal tissue undercut.
  • Patient should be with class I occlusion.
  • No occlusal disorder; stable jaw relation.
  • No TMD signs or symptoms.
  • Patients should be in generally good health and free of systemic conditions that can affect the implant treatment, such as diabetes mellitus.

You may not qualify if:

  • Patients with psychological or mental disorders.
  • Patients with insufficient interarch space.
  • Patients with parafunctional habits, such as bruxism.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Cairo University

Giza, 12511, Egypt

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Central Study Contacts

Noha Walid Barakat, Masters degree

CONTACT

Ahmed Mustafa Kotb, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Statistician
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations