NCT07179146

Brief Summary

A crossover study will be conducted on 20 pediatric patients aged 7-11 years. For each participant, the upper and lower study models will be processed using two methods: the conventional method, which involves alginate impressions, and the digital method, which utilizes a 3D intraoral digital scanner (CEREC Omnicam scanner or equivalent). Measurements of arch length, arch width, and arch depth will be taken from both model types using the conventional method with a brass wire and a digital caliper. At the same time, in the scan cast, they will be calculated digitally by 3D shape software. Statistical analysis will be done to compare the results of both methods.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 1, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

Dental arch analysis

Outcome Measures

Primary Outcomes (5)

  • Subjective outcome

    Patient acceptance will be recorded according to Modified Facial scale modified from the Maunuksela et al scale showing the 3 schematic faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.

    2 months

  • Objective Outcome (Measurement)

    arch width (inter canine and intermolar width) measured in mm

    2 months

  • Patient acceptance

    Frankl's behavior rating scale will be re-evaluated after each method used. Score 1-4. score 1=definitely positive, score 2=positive,score 3=negative,score 4=definitely negative.

    2 months

  • Objective Outcome (Measurement)

    Arch Length measured in mm

    2 months

  • Objective Outcome (Measurement)

    Arch depth measured in mm

    2 months

Study Arms (2)

Conventional Measurement

EXPERIMENTAL

Using brass wire and digital caliper

Device: Dental arch length anlysisBehavioral: child satisfactionDevice: Dental arch length anaylsisDevice: Dental arch length analysisDevice: Dental arch length anylsis

Digital Measurement

EXPERIMENTAL

Intraoral scanning using CEREC Omnicam scanner and digital models will be obtained

Device: Dental arch length anlysisBehavioral: child satisfactionDevice: Dental arch length anaylsisDevice: Dental arch length analysisDevice: Dental arch length anylsis

Interventions

Arch length

Conventional MeasurementDigital Measurement

Frankel rating scale

Conventional MeasurementDigital Measurement

Intermolar width

Conventional MeasurementDigital Measurement

Intercanine width

Conventional MeasurementDigital Measurement

Arch depth

Conventional MeasurementDigital Measurement

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy Children aged 7-11 years old (ASA 1).
  • Class I with normal development of occlusion .
  • Absence of dental extractions.
  • Absence of previous removable or fixed orthodontic treatments.
  • Patients with fully erupted permanent first molars.
  • Children with Frankel behavioral rating scale 2,3 and 4.

You may not qualify if:

  • Delayed erupted 1st permanent molar.
  • Teeth with severe rotation.
  • Dental agenesis.
  • Oligodontia.
  • Frankel behavioral rating scale 1.
  • Patients with special health care and medically compromised patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharos University in Alexandria

Alexandria, Egypt

RECRUITING

Central Study Contacts

Nehal Raid Salman, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
statistician
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric Dentistry department

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 17, 2025

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 15, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations