Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Not Applicable

• Conditions: Missing Teeth
• Interventions: Device: 3D printed space maintainer by NextDent Ortho Rigid; Device: Conventional Band and Loop

• Registration Number: NCT04221243
• Lead Sponsor: Farah Ahmed Barakat

Brief 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.

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 Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08
• Primary Completion: 2021-02-28
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Children with 3D printed space maintainer	3D printed space maintainer by NextDent Ortho Rigid	-
Group 2: Children with conventional band and loop	Conventional Band and Loop	-

Primary Outcome Measures

Name	Time	Method
introduce a new 3D printed design of an intraoral space maintainer.	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 Outcome Measures

Name	Time	Method
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.	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.	6 months	Patient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3)

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt