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CompletedNCT04730115Updated Oct 14, 2021

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

An observational study in Orthopedic Disorder, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 11 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
42
Ages
11 Years to 13 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Orthopedic Disorder

Keywords

  • Functional orthodontic appliances
  • fractal dimension
  • panoramic radiographs
  • orthodontics
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In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 160 are open to participants now.

This study's enrollment of 42 is below the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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 criteria

Exclusion Criteriteria:

  1. Radiographic images that do not have sufficient diagnostic quality
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Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
42 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: for one months from the beginning of the study

  2. 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

    Time frame: for one week from the beginning of the study

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04730115
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
DİLARA NİL GÜNAÇAR (assistant professor, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Jan 29, 2021
Start date
Sep 20, 2020
Primary completion
Nov 20, 2020
Completion
Dec 20, 2020
Last update
Oct 14, 2021

Study contacts

Dilara Nil Günaçar, 1
principal investigator · Recep Tayyip Erdogan University Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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