Orthopedic DisorderNCT04730115
Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis
An observational study of Orthopedic Disorder, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2020to 20 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 1. Radiographic images that do not have sufficient diagnostic quality
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
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.
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).
- Conditions
- Orthopedic Disorder
- Keywords
- Functional orthodontic appliances, fractal dimension, panoramic radiographs, orthodontics
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: for one week from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start20 Sep 2020
- Primary completion20 Nov 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Dilara Nil Günaçar, 1, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730115
- Sponsor's protocol ID
- 2020/199
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis
- ClinicalTrials.gov ID
- NCT04730115
- Acronym / sponsor ID
- 2020/199
- Conditions
- Orthopedic Disorder
- Keywords
- Functional orthodontic appliances, fractal dimension, panoramic radiographs, orthodontics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Radiographic images that do not have sufficient diagnostic quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilara Nil Günaçar, 1 principal investigator
Recep Tayyip Erdogan University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.