NCT07489027

Brief Summary

This randomized clinical study aimed to compare prosthetic complications and framework misfit associated with three different fabrication techniques of cobalt-chromium frameworks-conventional casting, CAD/CAM milling, and selective laser melting (SLM)-used in maxillary and mandibular full-arch implant-supported acrylic screw-retained restorations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 18, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 23, 2026

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

February 23, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

Full arch prosthesisCo-Cr frameworkCAD/CAM millingSelective laser melting

Outcome Measures

Primary Outcomes (1)

  • the number of occurance of Prosthetic complications

    The prosthetic complications were evaluated for the three different types of Co-Cr frameworks The following prosthetic complications were evaluated: * abutment screw loosening * abutment screw fracture * prosthetic screw loosening * prosthetic screw fracture * acrylic teeth fracture (separation) * acrylic teeth wear (replacement) * co-cr framework fracture

    after a year

Secondary Outcomes (1)

  • the implant framework Passive fit

    baseline

Study Arms (3)

Group I: Conventional cast Co-Cr framework

ACTIVE COMPARATOR

patients received maxillary and mandibular full-arch implant fixed prosthesis with conventional casting CO-CR framework

Device: Implant supported prosthesis

Group II: CAD/CAM milled Co-Cr framework

ACTIVE COMPARATOR

patients received maxillary and mandibular full-arch implant fixed prosthesis with milled CO-CR framework

Device: Implant supported prosthesis

Group III: Selective laser melting (SLM) Co-Cr framework

ACTIVE COMPARATOR

patients received maxillary and mandibular full-arch implant fixed prosthesis with a laser-melted CO-CR framework.

Device: Implant supported prosthesis

Interventions

All patients received maxillary and mandibular six implants to support a metal acrylic screw retained full-arch prosthesis

Group I: Conventional cast Co-Cr frameworkGroup II: CAD/CAM milled Co-Cr frameworkGroup III: Selective laser melting (SLM) Co-Cr framework

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Six osseointegrated maxillary and six mandibular implants
  • No clinical or radiographic signs of implant failure
  • Good systemic health
  • Normal maxillomandibular relationship and acceptable oral hygiene

You may not qualify if:

  • Implant failure
  • Unfavorable occlusal relationships
  • Poor compliance or inability to attend follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University , Faculty Of Dentistry

Al Mansurah, Dakahlia Governorate, P.O.Box:35516, Egypt

Location

MeSH Terms

Interventions

Dental Prosthesis, Implant-Supported

Intervention Hierarchy (Ancestors)

Dental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomly allocated to three equal groups (n = 9) by simple randomization:Group I: Conventional cast Co-Cr framework, Group II: CAD/CAM milled Co-Cr framework, and Group III: SLM Co-Cr framework
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 23, 2026

Study Start

January 18, 2024

Primary Completion

November 6, 2024

Study Completion

February 15, 2026

Last Updated

March 23, 2026

Record last verified: 2023-12

Locations