Space MaintenanceNCT07161076
Evaluation of a 3D Printed Space Maintainer Versus the Conventional Band and Loop
A study testing 3d Printed space maintainer and stainless steel band and loop in people with Space Maintenance and 3D Printing, run by British University In Egypt at 1 site in Egypt.
Trial summary
The goal of this study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Space Maintenance, 3D Printing, Primary Teeth
- What is being tested?
- 3d Printed space maintainer and stainless steel band and loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 21 Jul 2026
- 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
- Apparently healthy children.
- Children of both genders aged 6-9 years old.
- Guardians agree to join the study and sign the informed consent.
- Recent premature loss of primary first molars or having primary first molars indicated for extraction on both sides.
- Sound buccal and lingual surfaces of abutment teeth (primary second molar and primary canine).
- Good oral hygiene.
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- Absence of radiographic periapical pathology related to the abutment teeth.
- Absence of abnormal occlusal conditions such as posterior crossbite, deep bite, and scissor bite.
- All the indications for a band and loop space maintainer are met.
Who cannot join
- The patient is not able to attend regular follow-up visits.
- Allergic condition to any of the used materials.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The British University in Egypt , Pediatric Dentistry Clinic
El Shorouk, Cairo Governorate
About this study
Official title: Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study
The goal of this study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are:
- What is the clinical success rate of 3D printed space maintainers compared to traditional metal band and loop space maintainers over a 12-month period?
- How do 3D printed space maintainers compare in maintaining space and preventing rotation of abutment teeth?
- What are the differences in gingival health outcomes between the two types of space maintainers?
Read more
Participants (13 children aged 6-9 years) will:
Receive both devices in a "split-mouth" design (one on each side of the mouth), totaling 26 treated tooth spaces (13 per group).
Attend checkups every 3 months for a year to monitor the devices' performance.
- Conditions
- Space Maintenance, 3D Printing, Primary Teeth
- Being tested
- 3d Printed space maintainer, stainless steel band and loop
- Keywords
- 3d printing, resin 3d printed space maintainer, 3d printed, space maintainer, split mouth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d Printed space maintainerDevice
using Next dent permanent crown resin, a digitally designed space maintainer will be 3d printed to maintain space after extraction
stainless steel band and loopDevice
lab fabricated metal band and loop
| Study group | Role | What they receive |
|---|---|---|
| Metal Band and loop | Active comparator | Classic Stainless-steel Band and Loop , Control group Receives: Device: stainless steel band and loop |
| 3d Printed Resin band and loop | Experimental | 3d printed band and loop with the new design , using Permanent Crown resin Receives: Device: 3d Printed space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate of Space Maintainers
Percentage of space maintainers remaining functional without failure
Unit of Measure: Percentage of participants
Measured: 12 months
Gingival health index
measuring Gingival index for both space maintainers to compare the a ability of plaque to attach to both devices. scale 0-3, higher scores indicate worse gingival health
Measured: at 3-month follow-up, 6 months follow-up , and 1 year follow-up
Secondary outcomes (1)
Wong-Baker FACES Pain Rating Scale
Scale Range: 0 (no hurt) to 10 (hurts worst)
Interpretation: Higher scores indicate worse pain/lower satisfaction
Measured: immediately after cementation,at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 May 2024
- Primary completion30 Jan 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Space MaintenanceStudies 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
- Model description
- Split Mouth
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Suez Canal University
- Responsible party
- Principal investigator, Omar hodhod, British University In Egypt
- Investigators
- Omar A Hodhod, Principal investigator, The British University in Egypt , Suez canal university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161076
- Sponsor's protocol ID
- 648/2023
- Other IDs
- 648/2023
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel 3D Printed Space Maintainer Versus the Conventional Stainless-Steel Band and Loop: A Finite Element Analysis and In-Vivo Study
- ClinicalTrials.gov ID
- NCT07161076
- Acronym / sponsor ID
- 648/2023
- Conditions
- Space Maintenance, 3D Printing, Primary Teeth
- Keywords
- 3d printing, resin 3d printed space maintainer, 3d printed, space maintainer, split mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Suez Canal University
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 8 Sep 2025 (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 goal of this study is to evaluate whether a new 3D-printed dental device can effectively maintain space after premature loss of primary teeth in children, compared to the traditional stainless-steel device. It will also assess safety and comfort. The main questions it aims to answer are:
- What is the clinical success rate of 3D printed space maintainers compared to traditional metal band and loop space maintainers over a 12-month period?
- How do 3D printed space maintainers compare in maintaining space and preventing rotation of abutment teeth?
- What are the differences in gingival health outcomes between the two types of space maintainers?
Participants (13 children aged 6-9 years) will:
Receive both devices in a "split-mouth" design (one on each side of the mouth), totaling 26 treated tooth spaces (13 per group).
Attend checkups every 3 months for a year to monitor the devices' performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split Mouth
| Arm | Type | Receives |
|---|---|---|
| Metal Band and loop | Active comparator | Device: stainless steel band and loopClassic Stainless-steel Band and Loop , Control group |
| 3d Printed Resin band and loop | Experimental | Device: 3d Printed space maintainer3d printed band and loop with the new design , using Permanent Crown resin |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Apparently healthy children.
- Children of both genders aged 6-9 years old.
- Guardians agree to join the study and sign the informed consent.
- Recent premature loss of primary first molars or having primary first molars indicated for extraction on both sides.
- Sound buccal and lingual surfaces of abutment teeth (primary second molar and primary canine).
Key exclusion criteria (2 listed)
- The patient is not able to attend regular follow-up visits.
- Allergic condition to any of the used materials.
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 maintainerusing Next dent permanent crown resin, a digitally designed space maintainer will be 3d printed to maintain space after extraction | Device | 3d Printed Resin band and loop |
| stainless steel band and looplab fabricated metal band and loop | Device | Metal Band and loop |
Primary outcome
Clinical Success Rate of Space Maintainers
Time frame: 12 months
Percentage of space maintainers remaining functional without failure Unit of Measure: Percentage of participants
Gingival health index
Time frame: at 3-month follow-up, 6 months follow-up , and 1 year follow-up
measuring Gingival index for both space maintainers to compare the a ability of plaque to attach to both devices. scale 0-3, higher scores indicate worse gingival health
1 secondary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: immediately after cementation,at 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Space Maintenance
Active, not recruiting
3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.
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Recruiting
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Space Maintenance, Gingival Health
Recruiting
the Objective of This Research is to Compare the Clinical Effectiveness of the Conventional Lingual Arch Space Maintainers With Three-dimensional Printed Space Maintainers.
Gingival Health, Space Maintenance
Not yet recruitingObservational study
Space Changes After Premature Loss of Lower First Primary Molars in Children Using Digital Scanning
Premature Loss of Primary Molars, Space Maintenance
RecruitingObservational study
TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models
Oxidative Injury, Stress Physiological
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.
Omar A Hodhod principal investigator
The British University in Egypt , Suez canal university
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 and stainless steel band and loop in people with Space Maintenance and 3D Printing, run by British University In Egypt 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 29 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate of Space Maintainers (time frame: 12 months). The study lists 2 primary outcomes in all. 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 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.