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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion
• Intervention / Treatment: Device: Functional Pacifier; Behavioral: Stop habit

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlalberta Verna, DDS, PhD; Phone Number: 0041 061 2672641; Email: carlalberta.verna@unibas.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4058
    • Recruiting
    • UZB, University Center for Dental Medicine
    • Contact: Carlalberta Verna, DDS, PhD, Professor and Chair; Phone Number: +41 61 267 26 40; Email: carlalberta.verna@unibas.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Carlalberta Verna, DDS, PhD, University Center for Dental Medicine, Basel, Switzerland

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: UZB-Pacifier

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No