- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05771246
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Case group
Patients with third molar agenesis.
|
Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.
|
|
Control group
Patients with the presence of all third molars.
|
Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
March 6, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 7, 2023
Study Registration Dates
First Submitted
February 17, 2023
First Submitted That Met QC Criteria
March 4, 2023
First Posted (Actual)
March 16, 2023
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
July 6, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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