Missing TeethNCT04221243
Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One
A study testing 3D printed space maintainer by NextDent Ortho Rigid and Conventional Band and Loop in people with Missing Teeth, run by Farah Ahmed Barakat at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- 3D printed space maintainer by NextDent Ortho Rigid and Conventional Band and Loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Bad oral hygiene
- Medically Compromised patients.
- Presence of periapical pathology radiographically.
- Carious buccal and lingual surfaces of abutment teeth.
Trial locations and contacts
1 site in 1 country.
Islam Abbas, Phd contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 02
Farah Barakat, BDs, +201009887115, farah.barakat@bue.edu.eg
Islam Abbas, Phd, +201005111111
About this study
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.
Read the 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)
- Conditions
- Missing Teeth
- Being tested
- 3D printed space maintainer by NextDent Ortho Rigid, Conventional Band and Loop
- Keywords
- space maintainer, 3D printing
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed space maintainer by NextDent Ortho RigidDevice
Biocompatible 3D printing material
Conventional Band and LoopDevice
metal space maintainer
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Children with 3D printed space maintainer | Experimental | Not described Receives: Device: 3D printed space maintainer by NextDent Ortho Rigid |
| Group 2: Children with conventional band and loop | Active comparator | Not described Receives: Device: Conventional Band and Loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Aug 2019
- Primary completion28 Feb 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farah Ahmed Barakat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Farah Ahmed Barakat, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221243
- Sponsor's protocol ID
- PED-4M
- Status last verified
- Jul 2020
- First submitted
- 1 Oct 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Innovative 3D Printed Space Maintainer Versus Conventional One
- ClinicalTrials.gov ID
- NCT04221243
- Acronym / sponsor ID
- PED-4M
- Conditions
- Missing Teeth
- Keywords
- space maintainer, 3D printing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Farah Ahmed BarakatUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Children with 3D printed space maintainer | Experimental | Device: 3D printed space maintainer by NextDent Ortho Rigid |
| Group 2: Children with conventional band and loop | Active comparator | Device: Conventional Band and Loop |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Bad oral hygiene
- Medically Compromised patients.
- Presence of periapical pathology radiographically.
- Carious buccal and lingual surfaces of abutment teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed space maintainer by NextDent Ortho RigidBiocompatible 3D printing material | Device | Group 1: Children with 3D printed space maintainer |
| Conventional Band and Loopmetal space maintainer | Device | Group 2: Children with conventional band and loop |
Primary outcome
introduce a new 3D printed design of an intraoral space maintainer.
Time frame: 6 months
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 .
2 secondary outcomes
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their biological aspects.
Time frame: 6 months
compare between the new 3D printed space maintainer versus conventional metal band and loop regarding their patient satisfaction.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Islam Abbas, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed space maintainer by NextDent Ortho Rigid and Conventional Band and Loop in people with Missing Teeth, run by Farah Ahmed Barakat at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farah Barakat, BDs (+201009887115, farah.barakat@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
introduce a new 3D printed design of an intraoral space maintainer. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.