NCT07095374

Brief Summary

Recruitment of patients treated using rapid maxillary expanders with dental anchorage, with pre-treatment panoramic X-rays and post-treatment models. In the initial phase of the study, the objective is to correlate the radiographic inclination of the upper permanent premolars in the pre-treatment orthopantomography to the expansion obtained at the end of therapy using a palatal expander with dental anchorage.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress82%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

June 26, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

June 26, 2025

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of required activation for maxillary expansion

    Correlation between the number of activations of the rapid palatal expander and premolar inclination (angle between the long axis of the premolars with the occlusal plane)

    T0 (pre-treatment casts/x-rays) and T1 (post-treatment casts/x-rays)

Secondary Outcomes (1)

  • Canine inclination

    T0 (pre-treatment x-rays) and T1 (post-treatment x-rays)

Study Arms (1)

Orthodontic patients undergone rapid palatal expander treatment

Patients treated with rapid palatal expansion. Patients must have a pre-treatment and post-treatment orthopantomography.

Other: Rapid palatal expansion

Interventions

Patients undergone orthopedic treatment with rapid palatal expander

Orthodontic patients undergone rapid palatal expander treatment

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients referring to the Unit of Orthodontics and Pediatric Dentistry for oral care

You may qualify if:

  • Patients scheduled for orthopedic treatment with rapid palatal expander
  • Pre-treatment orthopantomography
  • Pre and post treatment intraoral scan

You may not qualify if:

  • Previous maxillofacial surgery
  • cleft lip and palate
  • premolar agenesis or extraction for fracture ecc.
  • Previous orthopedic-orthodontic treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andrea Scribante, DDS, phD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 31, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Data will be available upon motivated request to the principal investigator.

Locations