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Comparison of two screws for maxillary expansion in prepubertal children

Comparison of two screws for maxillary expansion in prepubertal children: a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18263886
Enrollment
56
Registered
2016-11-08
Start date
2016-09-05
Completion date
Unknown
Last updated
2024-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary arch constriction Oral Health

Interventions

Patients will be randomized to receive a screw for maxillary expansion that uses moderate and continuous forces (Memoria Leaf Spring Activated Expander A2704, Leone SpA) (test) or a standard expansion

Sponsors

Leone Orthodontics and Implantology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children in prepubertal stage (age between 6 and 14 years) 2. Negative posterior transverse discrepancy of at least 3 mm eligible for maxillary expansion 2. The first molars should be erupted with a mixed dentition stage in early transitional period or inter-transitional period

Exclusion criteria

Exclusion criteria: 1. Age older than 14 years or younger than 6 years 2. Deciduous dentition or mixed dentition in the late transitional period or permanent dentition 3. Maturation stage of cervical vertebrae CS3 or greater 4. Agenesis of maxillary second premolars 5. Periodontal disease 6. Neurologic or systemic disease 7. Allergy to nickel 8. Cleft lip and/or palate 9. Patients irradiated in the neck-head area 10. Chemo- or immune-therapy in the previous 5 years

Design outcomes

Primary

MeasureTime frame
1. Maxillary intermolar width, measured at baseline and at one-year follow-up 2. Pain, measured using a visual analogue scale (VAS) for the first 12 weeks (a total of 12 questionnaires)

Secondary

MeasureTime frame
1. Difficulties in speaking, measured using VAS every week for the first 12 weeks (a total of 12 questionnaires) 2. Difficulties in keeping the expander clean, measured using VAS every week for the first 12 weeks (a total of 12 questionnaires) 3. Treatment satisfaction of both the patients and the patients' parents, evaluated at one-year follow up 4. Complications, recorded during the 1-year follow up period 5. Variables either on dental casts or postero-anterior cephalograms, measured at baseline and at one-year follow up

Countries

Italy

Contacts

Public ContactLorenzo Franchi
lorenzo.franchi@unifi.it+39 (0)55 7945602

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026