ClinicalTrials.gg
Enrolling by invitationNCT06050187Updated Dec 20, 2023

Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch

An interventional study of implant casts fabrication in Prosthesis Durability, sponsored by Mansoura University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.

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

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 8 months after the study started (first participant enrolled Dec 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study summary

This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.

02

Conditions studied

  • Prosthesis Durability

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03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 20 is below the median of 36 across 69 interventional studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history.

      • Patients were free from all oral pathological conditions and any remaining roots which were verified by pre-operative panoramic radiograph.
      • Patients with U shaped arch, flat mandibular alveolar ridge covered with even compressibility healthy mucosa and gingival thickness of about 2mm verified by dual scan of cone beam computed tomography (CBCT) during treatment planning. Fig.(1)
      • Adequate residual alveolar bone quality D2 bone type in the anterior and premolar regions according to the Misch bone density classification scheme (850 to1250 housefield units) confirmed by CBCT.
      • Angel's class I maxillomandibular relation with moderate inter- arch space (20 mm) confirmed through tentative jaw relationship, and restorative space of at least 15 mm determined by putty index technique
      • Patients complain from poor retentive mandibular denture seeking for alternative fixed options.
      • Patient who is motivated, agreed with the follow-up visits and willing to return for follow-up appointments.

Exclusion criteria

Exclusion Criteria:

    • Patient with absolute that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy.

      • Patient with relative contraindication such as UN controlled diabetes mellitus, moderate smoking and alcoholism, patient with TMJ disorder and heavy smokers for more than10 cigarettes per day.
      • Patient with local contra indication as insufficient bone quality, localized lesion in canine area and premolar area, unfavourable position of the lower alveolar or mental nerve, bone defects as verified by cone beam CT.
      • Uncooperative patient.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Group I conventional stone cast

    Mandibular stone cast with 4 parallel implants analogues in canines and second premolar regions will be fabricated conventionally.

    Procedure: implant casts fabrication

  • Active comparator
    Group II 3D printed implant cast

    3D printed implant mandibular cast with 4 parallel digital implants analogues in canines and second premolar regions will be fabricated digitally.

    Procedure: implant casts fabrication

Interventions

  • Procedureimplant casts fabrication

    four implant casts fabricated

06

What researchers measure

Primary outcomes

  1. accuracy of 3D printed casts

    Accuracy of 3D printed casts will be evaluated digitally by geomagic software

    Time frame: 6 month

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 Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06050187
Responsible party
Sponsor
First posted
Sep 22, 2023
Start date
Dec 21, 2022
Primary completion
Dec 27, 2023 (estimated)
Completion
Dec 17, 2024 (estimated)
Last update
Dec 20, 2023

Oversight

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

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