Tooth AgenesisNCT05771246
Craniofacial Morphology And Sella Turcica Bridging Associated With Third Molar Agenesis.
An observational study of Tooth Agenesis, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Tooth Agenesis
- What is being tested?
- Radiographic evaluation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2023to 7 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.
Who may be able to join
- 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;
Who cannot join
- Ascertained previous surgical extraction/s of third molar/s
- Orthopedic/orthodontic therapy
- Orthognathic surgery.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: 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?
Read the 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.
- Conditions
- Tooth Agenesis
- Being tested
- Radiographic evaluation
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic evaluationDiagnostic test
Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients with third molar agenesis. Receives: Diagnostic Test: Radiographic evaluation | |
| Control group | Patients with the presence of all third molars. Receives: Diagnostic Test: Radiographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Linear regression between third molar agenesis and Interclinoid Distance
Distance between tuberculum sella (TS) and dorsum sella (DS).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start6 Mar 2023
- Primary completion1 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AgenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, Ms, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771246
- Sponsor's protocol ID
- 2023-AGENESISTHIRDMOLAR
- Status last verified
- Jul 2024
- First submitted
- 17 Feb 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Molar Agenesis Related To Craniofacial Pattern And Sella Turcica Bridging: A Retrospective Cephalometric Study
- ClinicalTrials.gov ID
- NCT05771246
- Acronym / sponsor ID
- 2023-AGENESISTHIRDMOLAR
- Conditions
- Tooth Agenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: Radiographic evaluationPatients with third molar agenesis. |
| Control group | – | Diagnostic Test: Radiographic evaluationPatients with the presence of all third molars. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- Ascertained previous surgical extraction/s of third molar/s
- Orthopedic/orthodontic therapy
- Orthognathic surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiographic evaluationPanoramic and lateral cephalometric radiographs with cephalometric analysis will be performed. | Diagnostic test | Case group, Control group |
Primary outcome
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)
Linear regression between third molar agenesis and Interclinoid Distance
Time frame: Baseline
Distance between tuberculum sella (TS) and dorsum sella (DS).
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.
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.
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, Ms, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Agenesis, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear regression between third molar agenesis and ANB (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.