NCT07593378

Brief Summary

To compare the effect of digital fabricated Nance and transpalatal arch appliances versus conventional fabricated Nance and transpalatal arch appliances.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Expected
Last Updated

May 18, 2026

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

May 8, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

nance spacemaintainerTPA appliance

Outcome Measures

Primary Outcomes (1)

  • arch parameters

    arch perimeter will be measured by 3d slicer software for digital prefabricated appliance and conventional fabricated appliance for both nance and TPA

    3 months

Secondary Outcomes (1)

  • arch width

    3 months

Study Arms (4)

digital Nance appliance

ACTIVE COMPARATOR

digital Nance appliance

Device: digital fabricated nance appliance

digital TPA appliance

ACTIVE COMPARATOR

digital TPA appliance

Device: digital TPA appliance

conventional nance appliance

OTHER

conventional nance appliance

Device: conventional nance appliance

conventional TPA appliance

OTHER

conventional TPA appliance

Device: conventional TPA appliance

Interventions

digital fabricated space maintainers

digital Nance appliance

digital fabricated space maintainer

digital TPA appliance

conventional fabricated nance appliance

conventional nance appliance

conventional fabricated TPA space maintainer

conventional TPA appliance

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharos Univeristy in Alexandria

Alexandria, Egypt

Location

Related Publications (1)

  • Change in Dental Arch Parameters-Perimeter, Width and Length after Treatment with a Printed RME Appliance Vladimir Bogdanov , Greta Yordanova and Gergana Gurgurova *

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 18, 2026

Study Start

June 2, 2025

Primary Completion

September 2, 2025

Study Completion (Estimated)

June 2, 2026

Last Updated

May 18, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations