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

Sponsor

Mansoura University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06050187

Collaborator

(none)

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prosthesis Durability	Device: mandibular overdenture	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch: A Comparative Study

Actual Study Start Date :

Dec 21, 2022

Anticipated Primary Completion Date :

Dec 27, 2023

Anticipated Study Completion Date :

Dec 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I conventional mandibular bar overdenture Mandibular overdenture splinted by 4 parallel implants in canines and second premolar regions will be fabricated conventionally.	Device: mandibular overdenture four implant supported bar mandibular overdenture
Active Comparator: Group II Milled mandibular bar overdenture milled mandibular overdenture splinted by parallel implants in canines and second premolar regions will be fabricated digitally.	Device: mandibular overdenture four implant supported bar mandibular overdenture

Arm

Intervention/Treatment

Active Comparator: Group I conventional mandibular bar overdenture

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

Device: mandibular overdenture

four implant supported bar mandibular overdenture

Active Comparator: Group II Milled mandibular bar overdenture

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

Device: mandibular overdenture

four implant supported bar mandibular overdenture

Outcome Measures

Primary Outcome Measures

accuracy of 3D printed casts [6 month]
Accuracy of 3D printed casts will be evaluated digitally by geomagic software

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT06050187

Other Study ID Numbers:

A07030123

First Posted:

Sep 22, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prosthesis Failure

Study Results

No Results Posted as of Sep 22, 2023