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The Use of a Pacifier to Correct Malocclusions in Young Children

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Pacifier
Stop habit
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Functional pacifier

    Stop habit

    Arm Description

    Swap from the habitual pacifier to a functional pacifier

    Stop the use of the habitual pacifier and or baby bottle

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Facial movement
    Lip contraction during swallowing of a sip of water
    Lip competence
    Contact between the upper and the lower lips at rest
    Facial morphology
    3D measurements of facial proportions

    Full Information

    First Posted
    April 27, 2018
    Last Updated
    June 8, 2020
    Sponsor
    University Hospital, Basel, Switzerland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03513003
    Brief Title
    The Use of a Pacifier to Correct Malocclusions in Young Children
    Official Title
    The Use of a Pacifier to Correct Malocclusions in Young Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Basel, Switzerland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malocclusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional pacifier
    Arm Type
    Experimental
    Arm Description
    Swap from the habitual pacifier to a functional pacifier
    Arm Title
    Stop habit
    Arm Type
    Active Comparator
    Arm Description
    Stop the use of the habitual pacifier and or baby bottle
    Intervention Type
    Device
    Intervention Name(s)
    Functional Pacifier
    Intervention Description
    Children swap from their habitual pacifier to the functional pacifier and stop baby bottle
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stop habit
    Intervention Description
    Children stop the use of their pacifier and/or baby bottle
    Primary Outcome Measure Information:
    Title
    Posterior cross bite
    Description
    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.
    Time Frame
    1 year
    Title
    Anterior open bite
    Description
    presence of anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Facial movement
    Description
    Lip contraction during swallowing of a sip of water
    Time Frame
    1 year
    Title
    Lip competence
    Description
    Contact between the upper and the lower lips at rest
    Time Frame
    1 year
    Title
    Facial morphology
    Description
    3D measurements of facial proportions
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carlalberta Verna, DDS, PhD
    Phone
    0041 061 2672641
    Email
    carlalberta.verna@unibas.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlalberta Verna, DDS, PhD
    Organizational Affiliation
    University Center for Dental Medicine, Basel, Switzerland
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20496855
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16532883
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25000602
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26399737
    Citation
    Filippi C, Filippi A, Verna C. Fruhkindliche kieferorthopadische Therapie mittels Schnuller? Swiss Dent J. 2015;125(9):959-70. French, German.
    Results Reference
    background
    PubMed Identifier
    29532184
    Citation
    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.
    Results Reference
    background

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    The Use of a Pacifier to Correct Malocclusions in Young Children

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