Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One

NCT ID: NCT04221243

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Missing Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Children with 3D printed space maintainer

Group Type EXPERIMENTAL

3D printed space maintainer by NextDent Ortho Rigid

Intervention Type DEVICE

Biocompatible 3D printing material

Group 2: Children with conventional band and loop

Group Type ACTIVE_COMPARATOR

Conventional Band and Loop

Intervention Type DEVICE

metal space maintainer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3D printed space maintainer by NextDent Ortho Rigid

Biocompatible 3D printing material

Intervention Type DEVICE

Conventional Band and Loop

metal space maintainer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Farah Ahmed Barakat

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Farah Ahmed Barakat

Teaching Assistant in British University in Egypt

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Farah Barakat, BDs

Role: CONTACT

+201009887115

Islam Abbas, Phd

Role: CONTACT

+201005111111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Farah Barakat, BDs

Role: primary

+201009887115

Islam Abbas, Phd

Role: backup

+201005111111

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PED-4M

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3D-printed Implant Overdentures
NCT04569929 COMPLETED NA