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NCT Number: NCT03513003

The Use of a Pacifier to Correct Malocclusions in Young Children

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZB, University Center for Dental Medicine

Basel, 4058, Switzerland

Location status: Recruiting

Location contact

Carlalberta Verna, DDS, PhD, Professor and Chair

CONTACT

[email protected]

+41 61 267 26 40

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Functional Pacifier

Device

Children swap from their habitual pacifier to the functional pacifier and stop baby bottle

Stop habit

Behavioral

Children stop the use of their pacifier and/or baby bottle

Primary outcomes

  1. Posterior cross bite

    Time frame: 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.

  2. Anterior open bite

    Time frame: 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 outcomes

  1. Facial movement

    Time frame: 1 year

    Lip contraction during swallowing of a sip of water

  2. Lip competence

    Time frame: 1 year

    Contact between the upper and the lower lips at rest

  3. Facial morphology

    Time frame: 1 year

    3D measurements of facial proportions

Study contacts

Contact information is provided by the study sponsor or research team.

Carlalberta Verna, DDS, PhD

CONTACT

[email protected]

0041 061 2672641

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 1, 2018
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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