The Use of a Pacifier to Correct Malocclusions in Young Children

Malocclusion Clinical Trial

Official title:

The Use of a Pacifier to Correct Malocclusions in Young Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03513003
• Other study ID #: UZB-Pacifier
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: January 2023

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: Carlalberta Verna, DDS, PhD
• Phone: 0041 061 2672641
• Email: carlalberta.verna[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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).

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Functional Pacifier
Children swap from their habitual pacifier to the functional pacifier and stop baby bottle

Behavioral:
• Stop habit
Children stop the use of their pacifier and/or baby bottle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

References & Publications (5)

Dimberg L, Bondemark L, Söderfeldt B, Lennartsson B. Prevalence of malocclusion traits and sucking habits among 3-year-old children. Swed Dent J. 2010;34(1):35-42. — View Citation

Filippi C, Filippi A, Verna C. Frühkindliche kieferorthopädische Therapie mittels Schnuller? Swiss Dent J. 2015;125(9):959-70. French, German. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Facial movement	Lip contraction during swallowing of a sip of water	1 year
Secondary	Lip competence	Contact between the upper and the lower lips at rest	1 year
Secondary	Facial morphology	3D measurements of facial proportions	1 year