The Use of a Pacifier to Correct Malocclusions in Young Children

NCT ID: NCT03513003

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-24

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Functional pacifier

Swap from the habitual pacifier to a functional pacifier

Group Type EXPERIMENTAL

Functional Pacifier

Intervention Type DEVICE

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

Stop habit

Stop the use of the habitual pacifier and or baby bottle

Group Type ACTIVE_COMPARATOR

Stop habit

Intervention Type BEHAVIORAL

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

Interventions

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Functional Pacifier

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

Intervention Type DEVICE

Stop habit

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlalberta Verna, DDS, PhD

Role: STUDY_CHAIR

University Center for Dental Medicine, Basel, Switzerland

Locations

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UZB, University Center for Dental Medicine

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Carlalberta Verna, DDS, PhD

Role: CONTACT

0041 061 2672641

Facility Contacts

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Carlalberta Verna, DDS, PhD, Professor and Chair

Role: primary

+41 61 267 26 40

References

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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.

Reference Type BACKGROUND
PMID: 20496855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16532883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25000602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26399737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29532184 (View on PubMed)

Other Identifiers

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UZB-Pacifier

Identifier Type: -

Identifier Source: org_study_id

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