Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

• Sponsor: Farah Ahmed Barakat (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04221243
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Missing Teeth	Device: 3D printed space maintainer by NextDent Ortho Rigid; Device: Conventional Band and Loop	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Feb 28, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt	02

Sponsors and Collaborators

• Farah Ahmed Barakat

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Farah Ahmed Barakat, Teaching Assistant in British University in Egypt, British University In Egypt
• ClinicalTrials.gov Identifier: NCT04221243
• Other Study ID Numbers: PED-4M
• First Posted: Jan 9, 2020
• Last Update Posted: Jul 8, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Farah Ahmed Barakat, Teaching Assistant in British University in Egypt, British University In Egypt: space maintainer; 3D printing
• Additional relevant MeSH terms: Tooth Loss; Anodontia

Study Results

No Results Posted as of Jul 8, 2020