Space MaintenanceTPANCT07593378
Efficacy of Digital Versus Conventional Nance and Transpalatal Arch Appliances for Space Maintenance
A study testing digital fabricated nance appliance, digital TPA appliance and conventional nance appliance in people with Space Maintenance, run by Pharos University in Alexandria at 1 site in Egypt.
Trial summary
To compare the effect of digital fabricated Nance and transpalatal arch appliances versus conventional fabricated Nance and transpalatal arch appliances. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Space Maintenance
- What is being tested?
- digital fabricated nance appliance, digital TPA appliance and conventional nance appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2025to 29 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 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 8-9 years
- Bilateral, prematurely extracted maxillary primary molars within a period not more than one month were selected.
- Fully erupted maxillary permanent first molars.
- Angle's class I occlusion.
- Adequate space for premolar eruption according to Moyer's arch length analysis.
Who cannot join
- Children with congenitally absent permanent successors.
- Children with successors not covered by bone.
- Children with successors with two-thirds or more of their roots formed.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effect of digital fabricated Nance and transpalatal arch appliances versus conventional fabricated Nance and transpalatal arch appliances.
Read the detailed description
measuring arch parameters: arch perimeter, anterior segment perimeter, maxillary width, anterior segment length, right molar rotation angle, left molar rotation angle, palatal vault depth
- Conditions
- Space Maintenance
- Being tested
- digital fabricated nance appliance, digital TPA appliance, conventional nance appliance, conventional TPA appliance
- Keywords
- nance spacemaintainer, TPA appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital fabricated nance applianceDevice
digital fabricated space maintainers
digital TPA applianceDevice
digital fabricated space maintainer
conventional nance applianceDevice
conventional fabricated nance appliance
conventional TPA applianceDevice
conventional fabricated TPA space maintainer
| Study group | Role | What they receive |
|---|---|---|
| digital Nance appliance | Active comparator | digital Nance appliance Receives: Device: digital fabricated nance appliance |
| digital TPA appliance | Active comparator | digital TPA appliance Receives: Device: digital TPA appliance |
| conventional nance appliance | Other | conventional nance appliance Receives: Device: conventional nance appliance |
| conventional TPA appliance | Other | conventional TPA appliance Receives: Device: conventional TPA appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
arch parameters
arch perimeter will be measured by 3d slicer software for digital prefabricated appliance and conventional fabricated appliance for both nance and TPA
Measured: 3 months
Secondary outcomes (1)
arch width
arch width will be measured by 3d slicer software for digital prefabricated appliance and conventional fabricated appliance for both nance and TPA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start2 Jun 2025
- Primary completion2 Sep 2025
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Salman, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593378
- Sponsor's protocol ID
- 407-02/09/2025
- Acronym
- TPA
- Status last verified
- Sep 2026
- First submitted
- 8 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Change in Dental Arch Parameters-Perimeter, Width and Length after Treatment with a Printed RME Appliance Vladimir Bogdanov , Greta Yordanova and Gergana Gurgurova *
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digital Versus Conventional Nance and Transpalatal Arch Appliances for Space Maintenance
- ClinicalTrials.gov ID
- NCT07593378
- Acronym / sponsor ID
- TPA / 407-02/09/2025
- Conditions
- Space Maintenance
- Keywords
- nance spacemaintainer, TPA appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 18 May 2026 (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.
To compare the effect of digital fabricated Nance and transpalatal arch appliances versus conventional fabricated Nance and transpalatal arch appliances.
Detailed description
measuring arch parameters: arch perimeter, anterior segment perimeter, maxillary width, anterior segment length, right molar rotation angle, left molar rotation angle, palatal vault depth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| digital Nance appliance | Active comparator | Device: digital fabricated nance appliancedigital Nance appliance |
| digital TPA appliance | Active comparator | Device: digital TPA appliancedigital TPA appliance |
| conventional nance appliance | Other | Device: conventional nance applianceconventional nance appliance |
| conventional TPA appliance | Other | Device: conventional TPA applianceconventional TPA appliance |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 8-9 years
- Bilateral, prematurely extracted maxillary primary molars within a period not more than one month were selected.
- Fully erupted maxillary permanent first molars.
- Angle's class I occlusion.
- Adequate space for premolar eruption according to Moyer's arch length analysis.
Key exclusion criteria (3 listed)
- Children with congenitally absent permanent successors.
- Children with successors not covered by bone.
- Children with successors with two-thirds or more of their roots formed.
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 |
|---|---|---|
| digital fabricated nance appliancedigital fabricated space maintainers | Device | digital Nance appliance |
| digital TPA appliancedigital fabricated space maintainer | Device | digital TPA appliance |
| conventional nance applianceconventional fabricated nance appliance | Device | conventional nance appliance |
| conventional TPA applianceconventional fabricated TPA space maintainer | Device | conventional TPA appliance |
Primary outcome
arch parameters
Time frame: 3 months
arch perimeter will be measured by 3d slicer software for digital prefabricated appliance and conventional fabricated appliance for both nance and TPA
1 secondary outcome
arch width
Time frame: 3 months
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 15 Sep 2026.
- BackgroundChange in Dental Arch Parameters-Perimeter, Width and Length after Treatment with a Printed RME Appliance Vladimir Bogdanov , Greta Yordanova and Gergana Gurgurova *
- Individual participant dataSharing planned: Yes
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
Clinical Evaluation of 3-D Printed Partial Denture Space Maintainer
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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.
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Active, not recruitingPhase 2
NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer
NPC
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
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital fabricated nance appliance, digital TPA appliance and conventional nance appliance in people with Space Maintenance, run by Pharos University in Alexandria 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 5 inclusion and 3 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 15 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?
arch parameters (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593378, which also lists 1 linked publication.
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 15 Sep 2026.