Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Missing Teeth Clinical Trial

Official title:

Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04221243
• Other study ID #: PED-4M
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2020
• Source: British University In Egypt
• Contact: Farah Barakat, BDs
• Phone: +201009887115
• Email: farah.barakat[@]bue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anodontia
• Missing Teeth
• Tooth Loss

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Farah Ahmed Barakat

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	introduce a new 3D printed design of an intraoral space maintainer.	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	compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.	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
Secondary	compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction.	Patient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3)	6 months