Craniofacial Morphology And Sella Turcica Bridging Associated With Third Molar Agenesis.

July 6, 2024 updated by: Andrea Scribante, University of Pavia

Third Molar Agenesis Related To Craniofacial Pattern And Sella Turcica Bridging: A Retrospective Cephalometric Study

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients referring for orthodontic consultation at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy, will be enrolled for the study according to the inclusion criteria. For each patient, lateral cephalometric radiograph and panoramic radiograph will be performed. For each lateral cephalometric radiograph, a cephalometric tracing will be performed with DeltaDent software (version 2.5.12, Outside Format, Pandino, Italy). Riedel's ANB angle [Riedel 1952] has been chosen to determine patients' skeletal class. Steiner's SN^GoGn angle [Steiner 1953] has been chosen to evaluate skeletal divergence. Facial axis (BaNa^CCGn), Lower Facial Height (LFH) and mandibular plan angle (FH^GoMe) from Rickett's analysis [Rickett's 1961] have been adopted to determine facial growth. According to Jaraback's cephalometric analysis [Jaraback 1985], saddle angle, articular angle, upper gonial angle, lower gonial angle will be measured to assess the growth pattern. Linear measurements of sella depth, sella diameter and interclinoid distance [Silverman 1957; Kisling 1966] will be calculated. Linear regressions between craniofacial patterns, sella turcica bridging and third molar agenesis will be calculated. A control group with no third molar agenesis will be provided.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Case group
Patients with third molar agenesis.
Diagnostic test: Radiographic evaluation
Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.
Control group
Patients with the presence of all third molars.
Diagnostic test: Radiographic evaluation
Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Linear regression between third molar agenesis and ANB
Time Frame: Baseline
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
Time Frame: Baseline
Distance between tuberculum sella (TS) and dorsum sella (DS).
Baseline
Linear regression between third molar agenesis and Sella Depth.
Time Frame: Baseline
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
Time Frame: Baseline
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.
Time Frame: Baseline
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
Time Frame: Baseline
Jaraback's Ar^Go^Gn is the angle formed between the 2 planes: ArGo and GoGn
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pavia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Scribante, DDS, Ms, PhD, University of Pavia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-AGENESISTHIRDMOLAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to the Principal Investigator

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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