Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2014-01-31
2019-03-31
Brief Summary
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NE is a common problem, affecting about 10% of school children. The prevalence declines with each year of maturity but for some it persists in to adolescents and early adulthood. It can lead to bad self-confidence and low self-esteem, which can have psychosocial consequences.
NE is a multifactorial condition. Three central factors have been identified:
A) Many bedwetting children produce large amounts of urine at night due to a deficiency of the antidiuretic hormone vasopressin.
B) Other children have a lack of inhibition of bladder emptying during sleep. C) Almost all children are deep sleepers with high arousal thresholds. They simply don't wake up when the bladder is full or when it contracts.
There are two well established and evidence based treatments today: the bed-wetting alarm and the pharmacologic treatment desmopressin. The alarm emits a sound when the child wets the bed, which conditions the child to wake up or inhibit bladder emptying. This method is curative for about half of the patients who try this, but relapse occurs. Desmopressin is a synthetic analog of arginine vasopressin and works by decreasing the urine volume at night. About half of the patients become dry with this medication but only as long as they take the medicine. To day, at least 25% of all children with NE do not respond to any of the above treatment.
Rapid maxillary expansion (RME) is a common orthodontic technique to treat patients with a narrow upper jaw. The brace is fitted by an orthodontist, and has a jack-screw, which is activated twice every day for 10-14 days. The procedure is neither painful nor harmful and is not very visible at all.
There are a few reports about children who have become dry after RME treatment. None of them have been randomised or placebo controlled but indicates that quite a few children do become dry after this treatment. A recently carried out study in Sweden show that half of the children became dry after RME treatment. These children were all classed as therapy resistant and had already tried the alarm and medication without success.
The reports are intriguing, but invite the question why a brace would help cure NE? It is likely that sleep and respiration is involved. This study will investigate these children's sleep during the treatment. The trial is a randomised, placebo controlled trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Rapid Maxillary Expansion
A Rapid Maxillary Expander will be fitted and the palate will be expanded approximately 5mm.
Rapid Maxillary Expansion
The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
Placebo group
A Sham appliance is fitted and activated for 10-14 days. The patients in this group will after it has been revealed they were randomized into the placebo group have a true Rapid Maxillary Expander fitted and the palate will be expanded approximately 5 mm.
Placebo Appliance
The Placebo Appliance looks exactly like the Rapid maxillary Expander but the expansion screw does not work. When the expansion screw is activated it does not create a palatal expansion.
Interventions
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Rapid Maxillary Expansion
The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
Placebo Appliance
The Placebo Appliance looks exactly like the Rapid maxillary Expander but the expansion screw does not work. When the expansion screw is activated it does not create a palatal expansion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 7 wet nights out of 14
Exclusion Criteria
* Constipation
* ADHD
7 Years
14 Years
ALL
No
Sponsors
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Örebro County Council
OTHER_GOV
Uppsala County Council, Sweden
OTHER_GOV
Uppsala University Hospital
OTHER
Responsible Party
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Ingrid Jönson Ring
Dr
Principal Investigators
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Ingrid M Jönson Ring, DDS, MSc
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Farhan Bazargani, DDS, PhD
Role: STUDY_DIRECTOR
Örebro County Council
Tryggve Nevéus, MD, PhD
Role: STUDY_CHAIR
Uppsala University Hospital
Locations
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Folktandvården Uppsala län
Uppsala, Uppland, Sweden
Countries
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References
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Bower WF, Moore KH, Shepherd RB, Adams RD. The epidemiology of childhood enuresis in Australia. Br J Urol. 1996 Oct;78(4):602-6. doi: 10.1046/j.1464-410x.1996.13618.x.
Neveus T. Nocturnal enuresis-theoretic background and practical guidelines. Pediatr Nephrol. 2011 Aug;26(8):1207-14. doi: 10.1007/s00467-011-1762-8. Epub 2011 Jan 26.
Timms DJ. Rapid maxillary expansion in the treatment of nocturnal enuresis. Angle Orthod. 1990 Fall;60(3):229-33; discussion 234. doi: 10.1043/0003-3219(1990)0602.0.CO;2.
Kurol J, Modin H, Bjerkhoel A. Orthodontic maxillary expansion and its effect on nocturnal enuresis. Angle Orthod. 1998 Jun;68(3):225-32. doi: 10.1043/0003-3219(1998)0682.3.CO;2.
Usumez S, Iseri H, Orhan M, Basciftci FA. Effect of rapid maxillary expansion on nocturnal enuresis. Angle Orthod. 2003 Oct;73(5):532-8. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
Schutz-Fransson U, Kurol J. Rapid maxillary expansion effects on nocturnal enuresis in children: a follow-up study. Angle Orthod. 2008 Mar;78(2):201-8. doi: 10.2319/021407-71.1.
Other Identifiers
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LUL-2012/379
Identifier Type: -
Identifier Source: org_study_id
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