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Trial registered on ANZCTR


Registration number
ACTRN12617001371381
Ethics application status
Approved
Date submitted
30/12/2016
Date registered
27/09/2017
Date last updated
27/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of foot orthotic treatment in child population with dental malocclusions. A pilot study.
Scientific title
The effect of foot orthotic treatment in patients with dental malocclusions in child population between 6-9 years old. A pilot study.
Secondary ID [1] 289668 0
Nil Known
Universal Trial Number (UTN)
U1111-1185-3017
Trial acronym
ETOMADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
FOOT POSTURE 299469 0
DENTAL MALOCCLUSIONS 299470 0
Condition category
Condition code
Oral and Gastrointestinal 299448 299448 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The oral treatment will be an orthodontic treatment. This treatment will be according to the needs and characteristics of the patient (could be brackets or a removable treatment). A dentist will deliver the intervention with minimum 5 years´ experience.

The foot treatment will be an insole.Type of Insole: Custom-made insoles will go to make with EVA material with the shore of 18 and 180 kg/cm3 and resins of PVC and manufactured by Formthotics, with an extension of 3/4. It will be in contact with heel and plantar arch. A podiatrist will be a supervisor of the intervention with minimum 5 years´ experience.

Assessment will be taken the first day(baseline), and the reviews will be at 6 months and 12 months.

We will have 3 arms of Treatment.

Arm 1: the treatment will be an oral treatment (orthodontic treatment) and a custom-made foot orthosis
Arm 2: the treatment will be only an oral treatment (orthodontic Treatment
Arm 3: the treatment will be only a custom-made orthosis

The variable to measure in each review will be the variables of foot posture index in the foot and the Angle´s dental classification at baseline, at six months and at twelve months. And we will compare with the last reviews

The Treatment of Foot orthosis will be used at least 8 hours per day and 5 days per week and only they could rest one week in all time of the study and the oral treatment will be using a length of the study.These treatments (orthodontic treatment and foot insole) will be worn for the 12 months of the study.
Intervention code [1] 296733 0
Treatment: Other
Intervention code [2] 297232 0
Treatment: Devices
Comparator / control treatment
The control treatment will be active. The treatment will be only an oral treatment (orthodontic Treatment) that it is the standard care in this case.
Control group
Active

Outcomes
Primary outcome [1] 300602 0
Proportion of participants with improvement in foot posture.
The foot posture will be assessed by the foot posture index (FPI), measured by a podiatrist with experience in the use of this tool, and blinded to the oral results.
Timepoint [1] 300602 0
Baseline, and at 6 and 12 months after intervention commencement.
Primary outcome [2] 300603 0
Proportion of participans with improvement in dental classification.
The dental classification will be assessed according to Angle´s classification., measured by an experinced dental practioner, blinded to the podiatric results.
Timepoint [2] 300603 0
Baseline, and 6 and 12 months after intervention commencement.
Secondary outcome [1] 332683 0
None
Timepoint [1] 332683 0
None

Eligibility
Key inclusion criteria
Inclusion criteria will be healthy children, to be between 6 to 9 years, have a dental malocclusion II or III in the Angle classification, and have a pronated or supinated foot by the criteria of Foot Posture Index. The parents will accept that the kid will be in the study and sign the informed consent. If the kid has the inclusion criteria will be randomized to one of them arms
Minimum age
6 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior surgery, to the lower limbs or the upper body.
2. Prior severe trauma that altered the child´s initial posture.
3. Prior orthodontic and/or orthosis treatment (support plantar).
4. Non-emergence of sufficient teeth to determinate the dental classification.
5. The presence of postural habits (indicated by parents) such as thumb sucking, sucking objects or tongue protusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
PILOT STUDY

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
Date of last participant enrolment
Anticipated
16/10/2017
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8529 0
Spain
State/province [1] 8529 0
Malaga

Funding & Sponsors
Funding source category [1] 295235 0
University
Name [1] 295235 0
University of Malaga
Country [1] 295235 0
Spain
Primary sponsor type
University
Name
University of Malaga
Address
Arquitecto Francisco Penalosa 3, 29071 Malaga
Country
Spain
Secondary sponsor category [1] 294065 0
Individual
Name [1] 294065 0
Ana Marchena Rodriguez
Address [1] 294065 0
Podofisio clinic and Carvajal and Ramirez dental clinic.
Calle Jose Maria Doblas, 1. 29730 Rincon de la Victoria (Malaga).
Country [1] 294065 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296577 0
Ethics Commitee of the University of Malaga
Ethics committee address [1] 296577 0
Ethics committee country [1] 296577 0
Spain
Date submitted for ethics approval [1] 296577 0
23/02/2015
Approval date [1] 296577 0
15/03/2016
Ethics approval number [1] 296577 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67402 0
Miss Ana Marchena Rodriguez
Address 67402 0
Podofisio clinic and Carvajal and Ramirez dental clinic.
Calle Jose Maria Doblas 1. 29730 Rincon de la Victoria (Malaga).
Country 67402 0
Spain
Phone 67402 0
+34 646136766
Fax 67402 0
Email 67402 0
gagijon@uma.es
Contact person for public queries
Name 67403 0
Ana Marchena Rodriguez
Address 67403 0
Podofisio clinic and Carvajal and Ramirez dental clinic.
Calle Jose Maria Doblas 1. 29730 Rincon de la Victoria (Malaga).
Country 67403 0
Spain
Phone 67403 0
+34 646136766
Fax 67403 0
Email 67403 0
gagijon@uma.es
Contact person for scientific queries
Name 67404 0
Ana Marchena Rodriguez
Address 67404 0
Podofisio clinic and Carvajal and Ramirez dental clinic.
Calle Jose Maria Doblas 1. 29730 Rincon de la Victoria (Malaga).
Country 67404 0
Spain
Phone 67404 0
+34 646136766
Fax 67404 0
Email 67404 0
gagijon@uma.es

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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