NCT05771246

Brief Summary

The aim of this retrospective study is to analyze the third molar agenesis with respect to sella turcica bridging and other craniofacial patterns in patients asking for orthodontic consultation. The main question\[s\] it aims to answer are:

  • is there a relationship between third molar agenesis and sella turchina bridging?
  • is there a relationship between third molar agenesis and craniofacial patterns?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 17, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

February 17, 2023

Last Update Submit

July 6, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Linear regression between third molar agenesis and ANB

    ANB is calculated according to Riedel's analysis: angle formed between Point A (maxillary sovraspinal point), point B (Bubmental mandibular point) and N (Nasion)

    Baseline

  • Linear regression between third molar agenesis and Interclinoid Distance

    Distance between tuberculum sella (TS) and dorsum sella (DS).

    Baseline

  • Linear regression between third molar agenesis and Sella Depth.

    Distance of a line dropped perpendicular from the interclinoid distance to the deepest point of the sella floor.

    Baseline

  • Linear regression between third molar agenesis and Sella Diameter

    Distance between tuberculum sella and the farthest point on the inner wall of the sella.

    Baseline

  • Linear regression between third molar agenesis and Sn^GoGn.

    Steiner's Sn\^GoGn is the angle formed between 2 planes: cranial base line (SN) and mandibular plane (GoGn)

    Baseline

  • Linear regression between third molar agenesis and ArGo^GoGn

    Jaraback's Ar\^Go\^Gn is the angle formed between the 2 planes: ArGo and GoGn

    Baseline

Study Arms (2)

Case group

Patients with third molar agenesis.

Diagnostic Test: Radiographic evaluation

Control group

Patients with the presence of all third molars.

Diagnostic Test: Radiographic evaluation

Interventions

Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.

Case groupControl group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.

You may qualify if:

  • G stage of Demirjian's classification for third molar maturation or absence of third molar germs
  • Patients with one lateral cephalometric digital radiograph executed in Natural Head Position (patients were asked to keep the teeth in contact and the lips relaxed).
  • Patients with panoramic radiograph;

You may not qualify if:

  • Ascertained previous surgical extraction/s of third molar/s
  • Orthopedic/orthodontic therapy
  • Orthognathic surgery.

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

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andrea Scribante, DDS, Ms, PhD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 16, 2023

Study Start

March 6, 2023

Primary Completion

June 1, 2023

Study Completion

June 7, 2023

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Data will be available upon motivated request to the Principal Investigator

Locations