Cone-Beam Computed TomographyNCT04346641
Correlation Between Facial Measurements and Tooth Size and Pulp Volume
An observational study of Cone-Beam Computed Tomography, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the correlation between the measurements of the specific points of the face (lower face height, midface height, the distance between zygomatic, pupillary distance,interalar distance, epicanthus distance, the distance between commissar) and the dimensions of the maxillary sixth… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Cone-Beam Computed Tomography
- What is being tested?
- Facial Measurements and Tooth Size and Pulp Volume
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2019to 13 Aug 2020
- 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 15 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Above 15 years old, healthy subjects
Who may be able to join
- Upper dental arches which have maxillary first molars
- At least one tooth which has no deep caries, filling or crown restoration must be
- No resorption or pathology in the root of the tooth which disrupt integrity must be
- Healthy subjects
Who cannot join
- Deep caries, filling or crown restoration
- Resorption or pathology in the root of the tooth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, 53000
Banu Arıcıoğlu, 05062272437, banu.arc@gmail.com
Fatma Pertek Hatipoğlu
About this study
Official title: Detection of Correlation Between Facial Measurements and Tooth Size and Pulp Volume Using Cone Beam Computed Tomography
The aim of this study was to investigate the correlation between the measurements of the specific points of the face (lower face height, midface height, the distance between zygomatic, pupillary distance,interalar distance, epicanthus distance, the distance between commissar) and the dimensions of the maxillary sixth molar tooth (mesiodistal distance, buccal palatal distance, root length, pulp volume).
Read the detailed description
Radiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. Facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, interalar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. Mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. The data obtained will be compared.
- Conditions
- Cone-Beam Computed Tomography
- Being tested
- Facial Measurements and Tooth Size and Pulp Volume
- Keywords
- Facial measurements, Dental measurements, Cone beam computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Measurements and Tooth Size and Pulp VolumeDiagnostic test
Radiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. Facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, inter alar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. Mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. The data obtained will be compared.
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of inferior face
Distance between subnasal and gnathion
Measured: 5 minute
Height of medium face
Distance between glabella and subnasal
Measured: 5 minute
bizygomatic distance
Distance from the most lateral parts of the arch of the zygomas
Measured: 5 minute
interpupillary distance
Distance the center of the pupil of the right side to the center of the pupil of the left side
Measured: 5 minute
interalar distance
Distance from ala of one side to other
Measured: 5 minute
Epicanthus distance
Distance from inner palpebral fissures
Measured: 5 minute
Commissural distance
Distance from commissar of the lips
Measured: 5 minute
Mesiobuccal root length
distance from enamel cement border of the tooth to the mesial root apex
Measured: 5 minute
Distobuccal root length
distance from enamel cement border of the tooth to the distal root apex
Measured: 5 minute
Palatal root length
distance from enamel cement border of the tooth to the palatal root apex
Measured: 5 minute
Mesiodistal width
Defined as the distance between two parallel planes, tangential to the most mesial and most distal points of the crown side
Measured: 5 minute
Buccal palatal width
Defined as the maximum distance between two parallel planes, one tangential to the most palatal point of the crown side, and the other tangential to a point on the buccal crown side
Measured: 5 minute
Inter first molar distance
The linear distance between right and left first molar teeth between the most convex palatal crown faces
Measured: 5 minute
Pulp volume
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start13 Dec 2019
- Primary completion13 Jun 2020 (estimated)
- Study completion13 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cone-Beam Computed TomographyStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA PERTEK HATİPOĞLU, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Banu Arıcıoğlu, Study director, Recep Tayyip Erdogan University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346641
- Sponsor's protocol ID
- No protocol ID
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Correlation Between Facial Measurements and Tooth Size and Pulp Volume Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT04346641
- Acronym / sponsor ID
- No protocol ID
- Conditions
- Cone-Beam Computed Tomography
- Keywords
- Facial measurements, Dental measurements, Cone beam computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 13 Jun 2020 (estimated)
- Study completion
- 13 Aug 2020 (estimated)
- First posted
- 15 Apr 2020 (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 study was to investigate the correlation between the measurements of the specific points of the face (lower face height, midface height, the distance between zygomatic, pupillary distance,interalar distance, epicanthus distance, the distance between commissar) and the dimensions of the maxillary sixth molar tooth (mesiodistal distance, buccal palatal distance, root length, pulp volume).
Detailed description
Radiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. Facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, interalar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. Mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. The data obtained will be compared.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Above 15 years old, healthy subjects
Key inclusion criteria (4 listed)
- Upper dental arches which have maxillary first molars
- At least one tooth which has no deep caries, filling or crown restoration must be
- No resorption or pathology in the root of the tooth which disrupt integrity must be
- Healthy subjects
Key exclusion criteria (2 listed)
- Deep caries, filling or crown restoration
- Resorption or pathology in the root of the tooth
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 |
|---|---|---|
| Facial Measurements and Tooth Size and Pulp VolumeRadiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. Facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, inter alar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. Mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. The data obtained will be compared. | Diagnostic test | – |
Primary outcome
Height of inferior face
Time frame: 5 minute
Distance between subnasal and gnathion
Height of medium face
Time frame: 5 minute
Distance between glabella and subnasal
bizygomatic distance
Time frame: 5 minute
Distance from the most lateral parts of the arch of the zygomas
interpupillary distance
Time frame: 5 minute
Distance the center of the pupil of the right side to the center of the pupil of the left side
interalar distance
Time frame: 5 minute
Distance from ala of one side to other
Epicanthus distance
Time frame: 5 minute
Distance from inner palpebral fissures
Commissural distance
Time frame: 5 minute
Distance from commissar of the lips
Mesiobuccal root length
Time frame: 5 minute
distance from enamel cement border of the tooth to the mesial root apex
Distobuccal root length
Time frame: 5 minute
distance from enamel cement border of the tooth to the distal root apex
Palatal root length
Time frame: 5 minute
distance from enamel cement border of the tooth to the palatal root apex
Mesiodistal width
Time frame: 5 minute
Defined as the distance between two parallel planes, tangential to the most mesial and most distal points of the crown side
Buccal palatal width
Time frame: 5 minute
Defined as the maximum distance between two parallel planes, one tangential to the most palatal point of the crown side, and the other tangential to a point on the buccal crown side
Inter first molar distance
Time frame: 5 minute
The linear distance between right and left first molar teeth between the most convex palatal crown faces
Pulp volume
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
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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.
Banu Arıcıoğlu study director
Recep Tayyip Erdogan University Faculty of Dentistry
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 Cone-Beam Computed Tomography, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Pertek Hatipoğlu (5074283749, pertekk_165@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height of inferior face (time frame: 5 minute). The study lists 14 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 15 Apr 2020.