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Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04221243
Enrollment
30
Registered
2020-01-09
Start date
2019-08-01
Completion date
2021-05-01
Last updated
2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Missing Teeth

Keywords

space maintainer, 3D printing

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)

Interventions

DEVICE3D printed space maintainer by NextDent Ortho Rigid

Biocompatible 3D printing material

metal space maintainer

Sponsors

Farah Ahmed Barakat
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
introduce a new 3D printed design of an intraoral space maintainer.6 monthsThe 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

MeasureTime frameDescription
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.6 monthsBiologically, 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 monthsPatient satisfaction will be assessed by a satisfaction questionnaire given to the patient (scale from 1-3)

Countries

Egypt

Contacts

Primary ContactFarah Barakat, BDs
farah.barakat@bue.edu.eg+201009887115
Backup ContactIslam Abbas, Phd
+201005111111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026