Efficacy of Digital Versus Conventional Nance and Transpalatal Arch Appliances for Space Maintenance (TPA)

May 13, 2026 updated by: Nehal Salman, Pharos University in Alexandria
To compare the effect of digital fabricated Nance and transpalatal arch appliances versus conventional fabricated Nance and transpalatal arch appliances.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Pharos Univeristy in Alexandria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: digital Nance appliance
Device: digital fabricated nance appliance
digital fabricated space maintainers
Active Comparator: digital TPA appliance
Device: digital TPA appliance
digital fabricated space maintainer
Other: conventional nance appliance
Device: conventional nance appliance
conventional fabricated nance appliance
Other: conventional TPA appliance
Device: conventional TPA appliance
conventional fabricated TPA space maintainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arch width
Time Frame: 3 months
arch width will be measured by 3d slicer software for digital prefabricated appliance and conventional fabricated appliance for both nance and TPA
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharos University in Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Actual)

September 2, 2025

Study Completion (Estimated)

June 2, 2026

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 407-02/09/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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