The Use of a Pacifier to Correct Malocclusions in Young Children

Not Applicable

Recruiting

• Conditions: Malocclusion
• Interventions: Device: Functional Pacifier; Behavioral: Stop habit

• Registration Number: NCT03513003
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-01
• Study Start: 2020-06-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional pacifier	Functional Pacifier	Swap from the habitual pacifier to a functional pacifier
Stop habit	Stop habit	Stop the use of the habitual pacifier and or baby bottle

Primary Outcome Measures

Name	Time	Method
Posterior cross bite	1 year	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.
Anterior open bite	1 year	presence of anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.

Secondary Outcome Measures

Name	Time	Method
Facial movement	1 year	Lip contraction during swallowing of a sip of water
Lip competence	1 year	Contact between the upper and the lower lips at rest
Facial morphology	1 year	3D measurements of facial proportions

Trial Locations

Locations (1)

UZB, University Center for Dental Medicine; 🇨🇭 Basel, Switzerland