Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJuly 8, 2020
July 1, 2020
1.6 years
October 1, 2019
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.
6 months
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction.
6 months
Study Arms (2)
Group 1: Children with 3D printed space maintainer
EXPERIMENTALGroup 2: Children with conventional band and loop
ACTIVE COMPARATORInterventions
Biocompatible 3D printing material
metal space maintainer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Bad oral hygiene
- Medically Compromised patients.
- Presence of periapical pathology radiographically.
- Carious buccal and lingual surfaces of abutment teeth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, 02, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Teaching Assistant in British University in Egypt
Study Record Dates
First Submitted
October 1, 2019
First Posted
January 9, 2020
Study Start
August 1, 2019
Primary Completion
February 28, 2021
Study Completion
May 1, 2021
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share