- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491619
Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities
December 10, 2017 updated by: Michelle Sendyk
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
SP
-
Sao Paulo, SP, Brazil
- University of Sao Paulo
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Brazilian nationality;
- Class III malocclusion, for molars and canines;
- Concave facial profile;
- Indications for orthodontic-surgical treatment;
- Craniofacial growth finalized ;
- Absence of tooth extractions;
- No local and / or general contraindications for surgery;
- No previous orthodontic-surgical treatment;
- Good dental and periodontal conditions.
Exclusion Criteria:
- 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.
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Orthodontic decompensation
Orthodontic decompensation in patients with class III dentofacial deformities
|
Evaluation of the correlation between bone thickness and tooth inclination previously and after orthodontic treatment of decompensation due to orthognathic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in tooth inclination and bone thickness after tooth decompensation
Time Frame: 12 months after the begginning of orthodontic treatment, prior to orthognathic surgery
|
12 months after the begginning of orthodontic treatment, prior to orthognathic surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: José Rino Neto, PhD, University of Sao Paulo
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
July 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
June 24, 2015
First Submitted That Met QC Criteria
July 2, 2015
First Posted (Estimate)
July 8, 2015
Study Record Updates
Last Update Posted (Actual)
December 12, 2017
Last Update Submitted That Met QC Criteria
December 10, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sendyk001
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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