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Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Primary Purpose

Missing Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3D printed space maintainer by NextDent Ortho Rigid
Conventional Band and Loop
Sponsored by
Farah Ahmed Barakat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Missing Teeth focused on measuring space maintainer, 3D printing

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Children with 3D printed space maintainer

Group 2: Children with conventional band and loop

Arm Description

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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
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)

Full Information

First Posted
October 1, 2019
Last Updated
July 7, 2020
Sponsor
Farah Ahmed Barakat
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1. Study Identification

Unique Protocol Identification Number
NCT04221243
Brief Title
Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One
Official Title
Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Farah Ahmed Barakat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
space maintainer, 3D printing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Children with 3D printed space maintainer
Arm Type
Experimental
Arm Title
Group 2: Children with conventional band and loop
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
3D printed space maintainer by NextDent Ortho Rigid
Intervention Description
Biocompatible 3D printing material
Intervention Type
Device
Intervention Name(s)
Conventional Band and Loop
Intervention Description
metal space maintainer
Primary Outcome Measure Information:
Title
introduce a new 3D printed design of an intraoral space maintainer.
Description
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 .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.
Description
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
Time Frame
6 months
Title
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction.
Description
Patient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farah Barakat, BDs
Phone
+201009887115
Email
farah.barakat@bue.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Islam Abbas, Phd
Phone
+201005111111
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farah Barakat, BDs
Phone
+201009887115
Email
farah.barakat@bue.edu.eg
First Name & Middle Initial & Last Name & Degree
Islam Abbas, Phd
Phone
+201005111111

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

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