Accuracy of 3-dimensional Printed Implant Cast Versus Con... | NCT06050187

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

NCT06050187

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Dec 20, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Prosthesis Durability

Interventions

implant casts fabrication

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2022Actual

Primary Completion Date

Dec 27, 2023Estimated

Completion Date

Dec 17, 2024Estimated

First Submitted Date

Sep 17, 2023

First Submission Date that Met QC Criteria

Sep 21, 2023

First Posted Date

Sep 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2023

Last Update Posted Date

Dec 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I conventional stone cast	Active Comparator	Mandibular stone cast with 4 parallel implants analogues in canines and second premolar regions will be fabricated conventionally.	Procedure: implant casts fabrication
Group II 3D printed implant cast	Active Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
implant casts fabrication	Procedure	four implant casts fabricated	Group I conventional stone cast Group II 3D printed implant cast

Measure	Description	Time Frame
accuracy of 3D printed casts	Accuracy of 3D printed casts will be evaluated digitally by geomagic software	6 month

Eligibility Module

Eligibility Criteria

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:

• Patient with absolute contraindications 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms