Evaluation of Impacted or Included Maxillary Canines on D... | NCT06996821

Studies
Evaluation of Impacted or Included Maxillary Canines on Dentofacial Structures, and Airway and Nasal Fossa Dimensions

NCT06996821

Sponsor

JAVIER MONTERO

Status

Completed

Last Update Posted

May 30, 2025Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Impacted Canines
Maxillary Sinus

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
01/321	Other Identifier	Universidas Alfonso X El Sabio

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Feb 1, 2025Actual

Completion Date

Feb 1, 2025Actual

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

May 26, 2025

First Posted Date

May 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2025

Last Update Posted Date

May 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study retrospectively analyzed previously acquired CBCT images to evaluate specific anatomical features, such as [e.g., "maxillary sinus and nasal fossa volumes"]. No active patient participation or new clinical procedures is required; this information is used to measure sinus and fossa dimensions.

Detailed Description

The study analysed the CBCTs of patients, each assigned to one of three groups: control, unilateral canine impaction, or bilateral canine impaction. Each group was assigned by gender. Three values were analysed: maxillary sinuses left (MSL) and right (MSR), and sinuses with fossa MSNF measures in mm3.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Different Volumes of Maxillary Sinuses and Nasal Airway Complex	Volume (in mm³) of the right maxillary sinus, left maxillary sinus, and combined nasal and maxillary sinus airway complex, measured using cone-beam computed tomography (CBCT) and Dolphin Imaging software. Measurements are performed in axial, coronal, and sagittal planes using standardized sensitivity and anatomical reference points.	November 2024 to February 2025

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral or bilateral canine inclusion,
young pacients between 10 and 23 years old.

Exclusion Criteria:

pregnant women,
major craniofacial deformities (such as cleft palate, severe asymmetric malocclusion, trauma or head & neck oncologic surgery),
surgeries other than maxillomandibular advancement,
patients with maxillary compression or syndromes
any nasal or nasopharyngeal airway obstruction.
skeletal, dental or dentoalveolar transversal or vertical issues

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

23 Years

Standard Ages

ChildAdult

Study Population

Orthodontic Department of Alfonxo X Sabio Masters' Clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Salamanca		Madrid			Spain