Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis

October 13, 2021 updated by: DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Actual)

42

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

  • Turkey
      • Rize, Turkey, 53100
        • Recep Tayyip Erdogan University Training and Research Hospital

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

11 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The database was taken from the archives between 2017 and 2019 in Recep Tayyip Erdogan University. The study will consist of 30 cases treated with the functional appliance and 12 control patients who had insufficient oral hygiene were not treated for one year. After providing oral care cases were treated orthodontically.

Description

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 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

Cohorts and Interventions

Group / Cohort
Group 1. The treatment group (T)
The treatment group comprised of 30 cases treated with functional appliance for one year in puberty.
Group 2. The control group (C)
The control group consists of 12 patients who had insufficient oral hygiene; didn't take any orthodontic treatment for one year.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Investigators

  • Principal Investigator: Dilara Nil Günaçar, 1, Recep Tayyip Erdogan University Training and Research Hospital

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 (ACTUAL)

September 20, 2020

Primary Completion (ACTUAL)

November 20, 2020

Study Completion (ACTUAL)

December 20, 2020

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (ACTUAL)

January 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/199

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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