MalocclusionNCT03513003
The Use of a Pacifier to Correct Malocclusions in Young Children
A study testing Functional Pacifier and Stop habit in people with Malocclusion, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Functional Pacifier and Stop habit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Jun 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
UZB, University Center for Dental Medicine
Basel, 4058
Carlalberta Verna, DDS, PhD, Professor and Chair, +41 61 267 26 40, carlalberta.verna@unibas.ch
About this study
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.
- Conditions
- Malocclusion
- Being tested
- Functional Pacifier, Stop habit
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional PacifierDevice
Children swap from their habitual pacifier to the functional pacifier and stop baby bottle
Stop habitBehavioural
Children stop the use of their pacifier and/or baby bottle
| Study group | Role | What they receive |
|---|---|---|
| Functional pacifier | Experimental | Swap from the habitual pacifier to a functional pacifier Receives: Device: Functional Pacifier |
| Stop habit | Active comparator | Stop the use of the habitual pacifier and or baby bottle Receives: Behavioral: Stop habit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Facial movement
Lip contraction during swallowing of a sip of water
Measured: 1 year
Lip competence
Contact between the upper and the lower lips at rest
Measured: 1 year
Facial morphology
3D measurements of facial proportions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start24 Jun 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlalberta Verna, DDS, PhD, Study chair, University Center for Dental Medicine, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513003
- Sponsor's protocol ID
- UZB-Pacifier
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2018
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20496855Warren 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.
PubMed 16532883Sousa 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.
PubMed 25000602Filippi 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.
PubMed 26399737Schmid 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.
PubMed 29532184
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Pacifier to Correct Malocclusions in Young Children
- ClinicalTrials.gov ID
- NCT03513003
- Acronym / sponsor ID
- UZB-Pacifier
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional pacifier | Experimental | Device: Functional PacifierSwap from the habitual pacifier to a functional pacifier |
| Stop habit | Active comparator | Behavioral: Stop habitStop the use of the habitual pacifier and or baby bottle |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional PacifierChildren swap from their habitual pacifier to the functional pacifier and stop baby bottle | Device | Functional pacifier |
| Stop habitChildren stop the use of their pacifier and/or baby bottle | Behavioural | Stop habit |
Primary outcome
Posterior cross bite
Time frame: 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.
Anterior open bite
Time frame: 1 year
presence of anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.
3 secondary outcomes
Facial movement
Time frame: 1 year
Lip competence
Time frame: 1 year
Facial morphology
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 20496855Dimberg 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.
- Background: PubMed 16532883Warren 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.
- Background: PubMed 25000602Sousa 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.
- Background: PubMed 26399737Filippi 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.
- Background: PubMed 29532184Schmid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlalberta Verna, DDS, PhD study chair
University Center for Dental Medicine, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Pacifier and Stop habit in people with Malocclusion, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlalberta Verna, DDS, PhD (0041 061 2672641, carlalberta.verna@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior cross bite (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513003, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.