Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2021

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)

Interventions

  • Device: 3D printed space maintainer by NextDent Ortho Rigid
    • Biocompatible 3D printing material
  • Device: Conventional Band and Loop
    • metal space maintainer

Arms, Groups and Cohorts

  • Experimental: Group 1: Children with 3D printed space maintainer
  • Active Comparator: Group 2: Children with conventional band and loop

Clinical Trial Outcome Measures

Primary Measures

  • 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 .

Secondary Measures

  • 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
  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 9 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Farah Ahmed Barakat
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Farah Ahmed Barakat, Teaching Assistant in British University in Egypt – British University In Egypt
  • Overall Contact(s)
    • Farah Barakat, BDs, +201009887115, farah.barakat@bue.edu.eg

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