Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

July 7, 2020 updated by: Farah Ahmed Barakat

The primary aim of this study is to introduce a new effective and efficient 3D printed design of an intra-oral space maintainer.

The secondary aim of the study is to:

Evaluate the clinical performance of 3D printed space maintainer versus conventional metal band and loop over a period of 6 months regarding their functional , biological aspects and patient satisfaction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

And will be conducted as follows:

  • In-Vivo evaluation of the clinical performance of 3D printed space maintainer versus metal band and loop concerning oral hygiene, retention and patient satisfaction.
  • A total of thirty healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University. They will be divided using simple randomization in two groups:

Group 1: Children with 3D printed space maintainer (n=15) Group 2: Children with conventional band and loop(n=15)

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Ain Shams University
        • Contact:
        • Contact:
          • Islam Abbas, Phd
          • Phone Number: +201005111111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 6-9years' old
  • Premature loss of primary molar or molars in one or more quadrant.
  • Absence of abnormal dental conditions such as cross bite.
  • Sound and healthy buccal and lingual surfaces of abutment teeth.

Exclusion Criteria:

  • Bad oral hygiene
  • Medically Compromised patients.
  • Presence of periapical pathology radiographically.
  • Carious buccal and lingual surfaces of abutment teeth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: Children with 3D printed space maintainer
Device: 3D printed space maintainer by NextDent Ortho Rigid
Biocompatible 3D printing material
ACTIVE_COMPARATOR: Group 2: Children with conventional band and loop
Device: Conventional Band and Loop
metal space maintainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
introduce a new 3D printed design of an intraoral space maintainer.
Time Frame: 6 months
The function of the new intraoral space maintainer will be assessed whether good retention is obtained or not,by checking whether it fell off the patient's mouth or not .
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.
Time Frame: 6 months
Biologically, the oral hygiene of the patient will be assessed by measuring the plaque and the gingival indices scores on the corresponding teeth on a scale from 0-3
6 months
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction.
Time Frame: 6 months
Patient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Farah Ahmed Barakat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ANTICIPATED)

February 28, 2021

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

January 6, 2020

First Posted (ACTUAL)

January 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED-4M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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