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Effectiveness of foot orthotic treatment in child population with dental malocclusions. A pilot study.

The effect of foot orthotic treatment in patients with dental malocclusions in child population between 6-9 years old. A pilot study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001371381
Acronym
ETOMADE
Enrollment
30
Registered
2017-09-27
Start date
2017-10-16
Completion date
2017-10-16
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to determinate the association, if any, between foot posture and dental malocclusions in the sagital axial, in children. we will have 3 groups of children: Intervention A: with orthodontic treatment and plantar support.. Intervention B: Only with orthodontic treatment. Intervention C: Only with support plantar. All the groups will be measure at the baseline, and at 6 and 12 months after intervention commencement.

Interventions

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 wi

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.

Sponsors

University of Malaga
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Years to 9 Years
Healthy volunteers
Yes

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026