Recruiting NCT03513003
The Use of a Pacifier to Correct Malocclusions in Young Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Pacifier, Stop habit.
- Who it may be relevant to
- Registry conditions: Malocclusion. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Functional Pacifier
Children swap from their habitual pacifier to the functional pacifier and stop baby bottle - Behavioral Stop habit
Children stop the use of their pacifier and/or baby bottle
Primary outcome measures
- Posterior cross bite [Time frame: 1 year]
- Anterior open bite [Time frame: 1 year]
Secondary outcome measures (3)
- Facial movement [Time frame: 1 year]
- Lip competence [Time frame: 1 year]
- Facial morphology [Time frame: 1 year]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- UZB, University Center for Dental Medicine — Basel
Publications
- Dimberg L, Bondemark L, Soderfeldt B, Lennartsson B. Prevalence of malocclusion traits and sucking habits among 3-year-old children. Swed Dent J. 2010;34(1):35-42. PMID 20496855
- Warren JJ, Slayton RL, Bishara SE, Levy SM, Yonezu T, Kanellis MJ. Effects of nonnutritive sucking habits on occlusal characteristics in the mixed dentition. Pediatr Dent. 2005 Nov-Dec;27(6):445-50. PMID 16532883
- Sousa RV, Pinto-Monteiro AK, Martins CC, Granville-Garcia AF, Paiva SM. Malocclusion and socioeconomic indicators in primary dentition. Braz Oral Res. 2014;28:54-60. doi: 10.1590/s1806-83242013005000032. PMID 25000602
- Filippi C, Filippi A, Verna C. [Orthodontic therapy in the early childhood using pacifier?]. Swiss Dent J. 2015;125(9):959-70. doi: 10.61872/sdj-2015-09-03. French, German. PMID 26399737
- Schmid KM, Kugler R, Nalabothu P, Bosch C, Verna C. The effect of pacifier sucking on orofacial structures: a systematic literature review. Prog Orthod. 2018 Mar 13;19(1):8. doi: 10.1186/s40510-018-0206-4. PMID 29532184
Identifiers
NCT: NCT03513003 · UZB-Pacifier