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

Primary Purpose

Prosthesis Durability

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mandibular overdenture
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Durability

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I conventional mandibular bar overdenture

Group II Milled mandibular bar overdenture

Arm Description

Mandibular overdenture splinted by 4 parallel implants in canines and second premolar regions will be fabricated conventionally.

milled mandibular overdenture splinted by parallel implants in canines and second premolar regions will be fabricated digitally.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 17, 2023
Last Updated
September 21, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06050187
Brief Title
Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch
Official Title
Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch: A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
December 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I conventional mandibular bar overdenture
Arm Type
Active Comparator
Arm Description
Mandibular overdenture splinted by 4 parallel implants in canines and second premolar regions will be fabricated conventionally.
Arm Title
Group II Milled mandibular bar overdenture
Arm Type
Active Comparator
Arm Description
milled mandibular overdenture splinted by parallel implants in canines and second premolar regions will be fabricated digitally.
Intervention Type
Device
Intervention Name(s)
mandibular overdenture
Intervention Description
four implant supported bar mandibular overdenture
Primary Outcome Measure Information:
Title
accuracy of 3D printed casts
Description
Accuracy of 3D printed casts will be evaluated digitally by geomagic software
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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