Dentofacial DeformitiesNCT02491619
Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities
A study testing orthodontic decompensation in people with Dentofacial Deformities, run by Michelle Sendyk at 1 site in Brazil.
Trial summary
The correlation between tooth inclination and bone thickness and the comparison between thickness measurements and buccolingual inclination before and after dental decompensation will be evaluated through tridimensional images in individuals with class III dentofacial deformities. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- orthodontic decompensation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Dec 2017
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Brazilian nationality;
- Class III malocclusion, for molars and canines;
- Concave facial profile;
- Indications for orthodontic-surgical treatment;
- Craniofacial growth finalized ;
- Absence of tooth extractions;
Show all 9Show fewer
- No local and / or general contraindications for surgery;
- No previous orthodontic-surgical treatment;
- Good dental and periodontal conditions.
Who cannot join
- Facial asymmetry;
- Absence of teeth (except the third molars);
- Periodontal disease and vertical or horizontal bone resorption;
- Extensive metal restorations;
- Previous orthodontic treatment;
- Root anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Buccolingual Dental Inclination and Bone Thickness After Orthodontic Decompensation in Patients With Class III Dentofacial Deformities
The correlation between tooth inclination and bone thickness and the comparison between thickness measurements and buccolingual inclination before and after dental decompensation will be evaluated through tridimensional images in individuals with class III dentofacial deformities.
Read the detailed description
Class III dentofacial deformity is associated with important functional, psychological and aesthetic changes and thus individuals affected by this type of deformity are motivated in seeking treatment. The sample will consist of three-dimensional images of 40 individuals with Class III dentofacial deformities. From these images generated by CBCT scans, the buccolingual inclinations of all teeth and maxillo-mandibular alveolar bone thickness in three different heights will be measured (3, 6 and 8 mm) from the cementoenamel junction through the Dolphin 3D® program. The 3D scans of the sample will be evaluated in two stages: the initial stage and after dental decompensation at the end of pre-surgical orthodontic phase. Pearson correlation test will be used to verify the relationship between tooth inclination and bone thickness. The thickness measurements and buccolingual inclination will be compared between treatment times (initial and pre-surgical) using paired Student t-test.
- Conditions
- Dentofacial Deformities
- Being tested
- orthodontic decompensation
- Keywords
- Angle class III, tomography, tooth inclination, bone thickness
- Medical subject headings
- Dentofacial Deformities, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic decompensationProcedure or surgery
Evaluation of the correlation between bone thickness and tooth inclination previously and after orthodontic treatment of decompensation due to orthognathic surgery
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic decompensation | Experimental | Orthodontic decompensation in patients with class III dentofacial deformities Receives: Procedure: orthodontic decompensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tooth inclination and bone thickness after tooth decompensation
Measured: 12 months after the begginning of orthodontic treatment, prior to orthognathic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Sendyk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michelle Sendyk, University of Sao Paulo
- Investigators
- José Rino Neto, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491619
- Sponsor's protocol ID
- sendyk001
- Status last verified
- Dec 2017
- First submitted
- 24 Jun 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Buccolingual Dental Inclination and Bone Thickness After Orthodontic Decompensation in Patients With Class III Dentofacial Deformities
- ClinicalTrials.gov ID
- NCT02491619
- Acronym / sponsor ID
- sendyk001
- Conditions
- Dentofacial Deformities
- Keywords
- Angle class III, tomography, tooth inclination, bone thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Michelle SendykUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- 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 correlation between tooth inclination and bone thickness and the comparison between thickness measurements and buccolingual inclination before and after dental decompensation will be evaluated through tridimensional images in individuals with class III dentofacial deformities.
Detailed description
Class III dentofacial deformity is associated with important functional, psychological and aesthetic changes and thus individuals affected by this type of deformity are motivated in seeking treatment. The sample will consist of three-dimensional images of 40 individuals with Class III dentofacial deformities. From these images generated by CBCT scans, the buccolingual inclinations of all teeth and maxillo-mandibular alveolar bone thickness in three different heights will be measured (3, 6 and 8 mm) from the cementoenamel junction through the Dolphin 3D® program. The 3D scans of the sample will be evaluated in two stages: the initial stage and after dental decompensation at the end of pre-surgical orthodontic phase. Pearson correlation test will be used to verify the relationship between tooth inclination and bone thickness. The thickness measurements and buccolingual inclination will be compared between treatment times (initial and pre-surgical) using paired Student t-test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthodontic decompensation | Experimental | Procedure: orthodontic decompensationOrthodontic decompensation in patients with class III dentofacial deformities |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Brazilian nationality;
- Class III malocclusion, for molars and canines;
- Concave facial profile;
- Indications for orthodontic-surgical treatment;
- Craniofacial growth finalized ;
Key exclusion criteria (6 listed)
- Facial asymmetry;
- Absence of teeth (except the third molars);
- Periodontal disease and vertical or horizontal bone resorption;
- Extensive metal restorations;
- Previous orthodontic treatment;
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 |
|---|---|---|
| orthodontic decompensationEvaluation of the correlation between bone thickness and tooth inclination previously and after orthodontic treatment of decompensation due to orthognathic surgery | Procedure or surgery | Orthodontic decompensation |
Primary outcome
Change in tooth inclination and bone thickness after tooth decompensation
Time frame: 12 months after the begginning of orthodontic treatment, prior to orthognathic surgery
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 12 Dec 2017.
Related trials for Dentofacial Deformities
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
Dentofacial Deformities, Orthognathic Surgery
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion
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.
José Rino Neto, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic decompensation in people with Dentofacial Deformities, run by Michelle Sendyk 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 9 inclusion and 6 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 12 Dec 2017. 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?
Change in tooth inclination and bone thickness after tooth decompensation (time frame: 12 months after the begginning of orthodontic treatment, prior to orthognathic surgery). 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 12 Dec 2017; AzTrials last refreshed its copy on 2 Nov 2026.