Clinical trial NCT03513003: The Use of a Pacifier to Correct Malocclusions in Young Children
Official title: The Use of a Pacifier to Correct Malocclusions in Young Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Posterior cross bite
timeFrame: 1 year
measure: Anterior open bite
timeFrame: 1 year
Secondary outcomes:
measure: Facial movement
timeFrame: 1 year
measure: Lip competence
timeFrame: 1 year
measure: Facial morphology
timeFrame: 1 year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: UZB, University Center for Dental Medicine
Study officials:
affiliation: University Center for Dental Medicine, Basel, Switzerland
name: Carlalberta Verna, DDS, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.