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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04730115
Other study ID # 2020/199
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2020
Est. completion date December 20, 2020

Study information

Verified date January 2021
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study it was aimed to examine the changes in mandibular bone after functional treatment by using fractal dimension (FD) and cortical thickness (CT) analysis.


Description:

In this study it was aimed to examine the changes in mandibular bone after functional treatment by using fractal dimension (FD) and cortical thickness (CT) analysis. The study will perform on 42 mandibular retrognathia cases. The treatment group (T), comprised of 30 cases treated with functional appliance for one year in puberty. The control group (C) consists of 12 patients who had insufficient oral hygiene; didn't take any orthodontic treatment for one year. FD and CT analysis will evaluate for both sides. FD measurements will perform on processus condylar, antigonial notch, and ramus regions in the panoramic radiographs. Paired t-test will apply to analyze all between groups (before (T1) and after treatment (T2), before (C1) and after (C2) control). Also, independent t-test wişll use to determine whether there was any difference between the treatment group (∆T=T2-T1) and the control group (∆C=C2-C1).


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 20, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 13 Years
Eligibility Inclusion Criteria: 1. Males and females were matched. 2. Treatment period of the treatment group was 1 year. 3. Observation period of the control group was also 1 year. 4. All groups had Class II malocclusion (ANB = 5) with the retrognathic mandible in the period of puberty and had no systemic problem and impacted teeth. 5. Monoblock and twin-block appliances were applied to the treatment group. 6. Patients in the control group had insufficient oral hygiene and after oral-care was provided, they were taken into treatment. Exclusion Criteriteria: 1. Radiographic images that do not have sufficient diagnostic quality

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Training and Research Hospital Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effect of functional treatment on the cortical structure of the mandible will be investigated by measuring cortical thickness. the effects of functional treatment with cortical thickness to cortical bone structure for one months from the beginning of the study
Primary Thanks to fractal dimension analysis, the effect of functional treatment on the trabecular bone structure of the mandible will be examined. the effects of functional treatment with fractal analysis to trabecular bone structure for one week from the beginning of the study
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