Condition category
Oral Health
Date applied
04/10/2016
Date assigned
08/11/2016
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The dental arches are the two arches of teeth, one on each jaw (upper and lower arch). A posterior crossbite is a misalignment of the teeth that occurs when the upper arch and/or the upper jaw are narrower than the lower arch, and can happen on one (unilateral) or both (bilateral) sides of the mouth. Treatment of a posterior crossbite usually involves expanding the upper arch with either a fixed or removable orthodontic appliance (brace). Expansion with fixed expanders may be more successful than removable expansion plates at correcting posterior crossbites in children. Growing patients may report undesirable side effects during the expansion phase with fixed expanders, such as pain and mouth ulcers. Pain could be reduced by modifying the amount of force applied during the expansion. It is not known whether an expansion screw that uses moderate and continuous force could cause less pain compared with a standard screw that uses heavy and intermittent force. The aim of this study is to compare the effectiveness and side effects of a screw for maxillary expansion that uses moderate and continuous force with a standard expansion screw that uses heavy and intermittent force.

Who can participate?
Children aged between 6 and 14 with a posterior crossbite

What does the study involve?
Participants are randomly allocated to be treated with one of two types of rapid maxillary expanders, either with an expansion screw that uses moderate and continuous force or a standard expansion screw that uses heavy and intermittent force. Participants are followed-up every 2 weeks during the active phase of expansion (about 3 months) and then they are checked every month until the completion of the study (1 year after the start of treatment).

What are the possible benefits and risks of participating?
Participants may benefit from correction of their posterior crossbite. The possible risks include pain and mouth ulcers.

Where is the study run from?
1. University of Florence (Italy)
2. University of Rome Tor Vergata (Italy)
3. University of Trieste (Italy)

When is the study starting and how long is it expected to run for?
January 2016 to September 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Lorenzo Franchi
lorenzo.franchi@unifi.it

Trial website

Contact information

Type

Public

Primary contact

Dr Lorenzo Franchi

ORCID ID

http://orcid.org/0000-0002-2072-460X

Contact details

Via del Ponte di Mezzo 46-48
Florence
50127
Italy
+39 (0)55 7945602
lorenzo.franchi@unifi.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LF1

Study information

Scientific title

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

Acronym

Study hypothesis

The objective of this randomized controlled trial (RCT) is to compare the efficacy and side effects of a screw for maxillary expansion that uses moderate and continuous forces (test) and a standard expansion screw that uses heavy and intermittent forces (control).

Ethics approval

Pediatric Ethics Committee of the Meyer Paediatric Hospital, 29/04/2016, ref: 57/2016

Study design

Three-centered superior parallel two-group randomized clinical trial with balanced randomization and blind examiner

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Maxillary arch constriction

Intervention

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 screw that uses heavy and intermittent forces (Rapid Expander with Telescopic Guides A2620, Leone SpA) (control).

Randomisation: Computer-generated, balanced, with allocation concealment by opaque sequentially numbered sealed envelopes.

The test expander will be activated by the operators every 2 weeks. The control expander will be activated (1/4 of a turn) by the parents of the patients every day. Patients will be followed-up every 2 weeks during the active phase of expansion (about 3 months) and then they will be checked every month until the completion of the study (1 year after the start of treatment).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

06/01/2016

Overall trial end date

05/09/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

72

Participant 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

Recruitment start date

05/09/2016

Recruitment end date

05/09/2018

Locations

Countries of recruitment

Italy

Trial participating centre

University of Florence
Department of Surgery and Translational Medicine
50127
Italy

Trial participating centre

University of Rome Tor Vergata
Department of Clinical Sciences and Medicine
00133
Italy

Trial participating centre

University of Trieste
Department of Medical and Surgical Sciences and Health
34149
Italy

Sponsor information

Organisation

Leone Orthodontics and Implantology

Sponsor details

Via P. a Quaracchi
50
Sesto Fiorentino (Firenze)
50019
Italy

Sponsor type

Industry

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Dr Lorenzo Franchi (lorenzo.franchi@unifi.it)

Intention to publish date

05/09/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes