Dental Arch Relationship AnomalyNCT03360513
Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.
An observational study of Dental Arch Relationship Anomaly, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study aims to determine the shape and dimension of dental arches from a lingual perspective, and determine shape and size used for lingual Orthodontics. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Arch Relationship Anomaly
- What is being tested?
- general group
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2016to 30 Mar 2019
- 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 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the shape and dimension of dental arches from a lingual perspective, and determine shape and size used for lingual Orthodontics.
Read the detailed description
The study sample comprised 70 Caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. Maxillary and mandibular dental casts were digitized (3D) and the images were analyzed by Delcam Power SHAPET 2010 software. Landmarks on the lingual surface of teeth were selected to determine the shape and size of dental arches.
- Conditions
- Dental Arch Relationship Anomaly
- Being tested
- general group
- Keywords
- Orthodontics, Dental arch, Orthodontic appliance design.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general groupOther
The sample comprised maxillary and mandibular dental casts of 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years, all of which had natural normal occlusion with at least four of the six keys to normal occlusion. 14 The first item of the first key was considered essential for sample selection(Angle Class I molar relationship). Another inclusion criterion was that individuals should be at least 15 years of age with no odontogenic abnormalities and all permanent teeth in occlusion.
| Study group | Role | What they receive |
|---|---|---|
| general group | Comprised 70 caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. Receives: Other: general group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistic study
describe arch form similar a mushroom arch
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Aug 2016
- Primary completion1 Nov 2017
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Arch Relationship AnomalyStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Cappellette Jr , PhD,DDS, Federal University of São Paulo
- Investigators
- Shirley SN Pignatari, PHD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360513
- Sponsor's protocol ID
- FUSãoPaulo15
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The 70 pairs of cast models were digitized with a 3D Dental Wings™ Scanner (model DW5-140, Montreal, Quebec, Canada). Images were analyzed by Delcam Power SHAPE™ software (2010, Birmingham, UK).
Publications
Lombardo L, Saba L, Scuzzo G, Takemoto K, Oteo L, Palma JC, Siciliani G. A new concept of anatomic lingual arch form. Am J Orthod Dentofacial Orthop. 2010 Sep;138(3):260.e1-260.e13; discussion 260-1. doi: 10.1016/j.ajodo.2010.04.022.
PubMed 20816292
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.
- ClinicalTrials.gov ID
- NCT03360513
- Acronym / sponsor ID
- FUSãoPaulo15
- Conditions
- Dental Arch Relationship Anomaly
- Keywords
- Orthodontics, Dental arch, Orthodontic appliance design.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 4 Dec 2017 (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.
This study aims to determine the shape and dimension of dental arches from a lingual perspective, and determine shape and size used for lingual Orthodontics.
Detailed description
The study sample comprised 70 Caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. Maxillary and mandibular dental casts were digitized (3D) and the images were analyzed by Delcam Power SHAPET 2010 software. Landmarks on the lingual surface of teeth were selected to determine the shape and size of dental arches.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general group | – | Other: general groupComprised 70 caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| general groupThe sample comprised maxillary and mandibular dental casts of 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years, all of which had natural normal occlusion with at least four of the six keys to normal occlusion. 14 The first item of the first key was considered essential for sample selection(Angle Class I molar relationship). Another inclusion criterion was that individuals should be at least 15 years of age with no odontogenic abnormalities and all permanent teeth in occlusion. | Other | general group |
Primary outcome
Statistic study
Time frame: six months
describe arch form similar a mushroom arch
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 14 Aug 2023.
- Results publication: PubMed 20816292Lombardo L, Saba L, Scuzzo G, Takemoto K, Oteo L, Palma JC, Siciliani G. A new concept of anatomic lingual arch form. Am J Orthod Dentofacial Orthop. 2010 Sep;138(3):260.e1-260.e13; discussion 260-1. doi: 10.1016/j.ajodo.2010.04.022.
- Individual participant dataSharing planned: No. The 70 pairs of cast models were digitized with a 3D Dental Wings™ Scanner (model DW5-140, Montreal, Quebec, Canada). Images were analyzed by Delcam Power SHAPE™ software (2010, Birmingham, UK).
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.
Shirley SN Pignatari, PHD principal investigator
Federal University of São Paulo
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 Dental Arch Relationship Anomaly, run by Federal University of São Paulo at 1 site in Brazil.
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 0 inclusion and 1 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 14 Aug 2023. 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 Brazil. 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?
Statistic study (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360513, which also lists 1 linked publication.
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 14 Aug 2023.