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Completed

NCT Number: NCT04730115

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

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.

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Key information

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females were matched.
  • Treatment period of the treatment group was 1 year.
  • Observation period of the control group was also 1 year.
  • 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.
  • Monoblock and twin-block appliances were applied to the treatment group.
  • Patients in the control group had insufficient oral hygiene and after oral-care was provided, they were taken into treatment.

Exclusion Criteriteria:

  • Radiographic images that do not have sufficient diagnostic quality

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2021
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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