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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04221243
Other study ID # PED-4M
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date May 1, 2021

Study information

Verified date July 2020
Source British University In Egypt
Contact Farah Barakat, BDs
Phone +201009887115
Email farah.barakat@bue.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 1, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 9 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
3D printed space maintainer by NextDent Ortho Rigid
Biocompatible 3D printing material
Conventional Band and Loop
metal space maintainer

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Farah Ahmed Barakat

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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