The Use of a Pacifier to Correct Malocclusions in Young Children

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03513003
Collaborator
(none)
200
2
28

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Functional Pacifier
  • Behavioral: Stop habit
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Use of a Pacifier to Correct Malocclusions in Young Children
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Facial movement [1 year]

    Lip contraction during swallowing of a sip of water

  2. Lip competence [1 year]

    Contact between the upper and the lower lips at rest

  3. Facial morphology [1 year]

    3D measurements of facial proportions

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03513003
Other Study ID Numbers:
  • UZB-Pacifier
First Posted:
May 1, 2018
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2020