NCT04730115

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
Last Updated

October 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 22, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

Functional orthodontic appliancesfractal dimensionpanoramic radiographsorthodontics

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • \. Radiographic images that do not have sufficient diagnostic quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Dilara Nil Günaçar, 1

    Recep Tayyip Erdogan University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 29, 2021

Study Start

September 20, 2020

Primary Completion

November 20, 2020

Study Completion

December 20, 2020

Last Updated

October 14, 2021

Record last verified: 2021-01

Locations