Comparison of two screws for maxillary expansion in prepubertal childre

Not Applicable

Completed

• Conditions: Maxillary arch constriction; Oral Health

• Registration Number: ISRCTN18263886
• Lead Sponsor: eone Orthodontics and Implantology

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33215652/ results (added 23/11/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34114608/ (added 14/06/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38168740/ (added 04/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-08
• Study Completion: 2019-11-30
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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