The Use of a Pacifier to Correct Malocclusions in Young Children

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of a pacifier (102 Medical Pacifier, Curaprox, Switzerland) on malocclusions like posterior crossbite, anterior open bite, larger overjet and tongue dysfunction in young children.

Official Title
-----------------
The Use of a Pacifier to Correct Malocclusions in Young Children

Conditions
-----------------
Malocclusion

Intervention / Treatment
-----------------
* Device: Functional Pacifier
* Behavioral: Stop habit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who are sucking the pacifier and / or baby bottle for the last 6 months in use. Manifesting posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite. AND / OR - Manifesting anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust. Exclusion Criteria: Children who are thumb- or fingersucking (or sucking other objects) syndromic or cleft patients patients with history of cranio-facial trauma, history of temporomandibular joint infection or musculo-skeletal asymmetry (e.g. scoliosis, torticollis) patients with systematic diseases patients currently under or after orthodontic Treatment patients with ankylosed teeth (e.g. after dental trauma).

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional pacifier<br>Swap from the habitual pacifier to a functional pacifier | Device: Functional Pacifier<br>* Children swap from their habitual pacifier to the functional pacifier and stop baby bottle<br>|
| Active Comparator: Stop habit<br>Stop the use of the habitual pacifier and or baby bottle | Behavioral: Stop habit<br>* Children stop the use of their pacifier and/or baby bottle<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior cross bite | presence of posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite. | 1 year | 
| Anterior open bite | presence of anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial movement | Lip contraction during swallowing of a sip of water | 1 year | 
| Lip competence | Contact between the upper and the lower lips at rest | 1 year | 
| Facial morphology | 3D measurements of facial proportions | 1 year |