NCT03513003

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2020Dec 2027

First Submitted

Initial submission to the registry

April 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 24, 2020

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

7.4 years

First QC Date

April 27, 2018

Last Update Submit

April 9, 2025

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Facial movement

    1 year

  • Lip competence

    1 year

  • Facial morphology

    1 year

Study Arms (2)

Functional pacifier

EXPERIMENTAL

Swap from the habitual pacifier to a functional pacifier

Device: Functional Pacifier

Stop habit

ACTIVE COMPARATOR

Stop the use of the habitual pacifier and or baby bottle

Behavioral: Stop habit

Interventions

Functional PacifierDEVICE

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

Functional pacifier
Stop habitBEHAVIORAL

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

Stop habit

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZB, University Center for Dental Medicine

Basel, 4058, Switzerland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 20496855BACKGROUND

  • 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.

    PMID: 16532883BACKGROUND

  • 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.

    PMID: 25000602BACKGROUND

  • 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.

    PMID: 26399737BACKGROUND

  • 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.

    PMID: 29532184BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Carlalberta Verna, DDS, PhD

    University Center for Dental Medicine, Basel, Switzerland

    STUDY CHAIR

Central Study Contacts

Carlalberta Verna, DDS, PhD

CONTACT

0041 061 2672641carlalberta.verna@unibas.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 1, 2018

Study Start

June 24, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)