Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Farah Ahmed Barakat

Status: Unknown

Conditions: Missing Teeth

Treatments: Device: 3D printed space maintainer by NextDent Ortho Rigid; Device: Conventional Band and Loop

Study type: Interventional

Funder types: Other

Identifiers

NCT04221243

PED-4M

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group 1: Children with 3D printed space maintainer

Experimental group

Treatment:

Device: 3D printed space maintainer by NextDent Ortho Rigid

Group 2: Children with conventional band and loop

Active Comparator group

Treatment:

Device: Conventional Band and Loop