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Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities

Primary Purpose

Dentofacial Deformities

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

orthodontic decompensation

About this trial

This is an interventional diagnostic trial for Dentofacial Deformities focused on measuring Angle class III, tomography, tooth inclination, bone thickness

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orthodontic decompensation

Arm Description

Orthodontic decompensation in patients with class III dentofacial deformities

Outcomes

Primary Outcome Measures

Change in tooth inclination and bone thickness after tooth decompensation

Secondary Outcome Measures

Full Information

NCT ID

NCT02491619

First Posted

June 24, 2015

Last Updated

December 10, 2017

Sponsor

Michelle Sendyk

1. Study Identification

Unique Protocol Identification Number

NCT02491619

Brief Title

Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities

Official Title

Correlation Between Buccolingual Dental Inclination and Bone Thickness After Orthodontic Decompensation in Patients With Class III Dentofacial Deformities

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michelle Sendyk

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dentofacial Deformities

Keywords

Angle class III, tomography, tooth inclination, bone thickness

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orthodontic decompensation

Arm Type

Experimental

Arm Description

Orthodontic decompensation in patients with class III dentofacial deformities

Intervention Type

Procedure

Intervention Name(s)

orthodontic decompensation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in tooth inclination and bone thickness after tooth decompensation

Time Frame

12 months after the begginning of orthodontic treatment, prior to orthognathic surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Rino Neto, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Study Chair

Facility Information:

Facility Name

University of Sao Paulo

City

Sao Paulo

State/Province

Country

Brazil

12. IPD Sharing Statement

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Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities

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