Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Study Overview
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Brief Summary
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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
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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)

Official Title
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Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Conditions
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Missing Teeth

Intervention / Treatment
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* Device: 3D printed space maintainer by NextDent Ortho Rigid
* Device: Conventional Band and Loop


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Children with 3D printed space maintainer<br> | Device: 3D printed space maintainer by NextDent Ortho Rigid<br>* Biocompatible 3D printing material<br>|
| Active Comparator: Group 2: Children with conventional band and loop<br> | Device: Conventional Band and Loop<br>* metal space maintainer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 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. | Patient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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space maintainer, 3D printing