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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02491619
Other study ID # sendyk001
Secondary ID
Status Completed
Phase N/A
First received June 24, 2015
Last updated December 10, 2017
Start date July 2015
Est. completion date December 2017

Study information

Verified date December 2017
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
orthodontic decompensation
Evaluation of the correlation between bone thickness and tooth inclination previously and after orthodontic treatment of decompensation due to orthognathic surgery

Locations

Country Name City State
Brazil University of Sao Paulo Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Michelle Sendyk

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in tooth inclination and bone thickness after tooth decompensation 12 months after the begginning of orthodontic treatment, prior to orthognathic surgery
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