NCT06050187

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
Last Updated

December 20, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 17, 2023

Last Update Submit

December 13, 2023

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (1)

  • accuracy of 3D printed casts

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

    6 month

Study Arms (2)

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

implant casts fabricationPROCEDURE

four implant casts fabricated

Group I conventional stone castGroup II 3D printed implant cast

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 22, 2023

Study Start

December 21, 2022

Primary Completion

December 27, 2023

Study Completion

December 17, 2024

Last Updated

December 20, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)