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Trial registered on ANZCTR


Trial ID
ACTRN12614000899640
Ethics application status
Approved
Date submitted
20/07/2014
Date registered
25/08/2014
Date last updated
25/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of orthodontic rapid maxillary expansion on nocturnal enuresis (bedwetting) in children.
Scientific title
A prospective study of rapid maxillary expansion (RME) outcomes on reducing the incidence and severity of nocturnal enuresis in children
Secondary ID [1] 285018 0
Nil
Universal Trial Number (UTN)
U1111-1159-4790
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nocturnal enuresis 292532 0
Condition category
Condition code
Renal and Urogenital 292838 292838 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 293087 293087 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children with nocturnal enuresis will be enrolled to the study. Parents or legal guardians will fill in the initial information survey. Intensity level of nocturnal enuresis will be described with the use of a 4-grade scale prepared for the purposes of the examination, that is 4 – a couple of times during the night, 3 – once during the night, 2 – once or a couple of times during the week and 1 – once or a couple of times during the month. The orthodontic part will involve preparing and analysis of diagnostic dental casts. The analysis of dental casts will be performed in comparison to generally assumed standards for white Caucasian race. Patients implementing inclusion criteria will be subjected to rapid maxillary expansion (RME). RME widens the skeletal structure of upper jaw by means of the mechanism of distraction osteogenesis. Bone distraction takes place on the level of palatal suture with special expansion device (for example Hyrax appliance). The device is applied once for the whole period of treatment and remains in the patient's mouth for about 9 weeks. By means of a special long key, the expansion screw can be unscrewed, so that a narrow upper jaw achieves the correct relationship with the lower jaw. Children from both groups A (subjected to RME and B (without RME) will be monitored in monthly intervals for the period of 12 months towards the intensification of bed-wetting. After 3 years of observation, at the end of research, parents and guardians of children from both groups A and B will be asked to reply to the question concerning the occurrence and frequency of bed-wetting.
Intervention code [1] 289852 0
Treatment: Devices
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 292705 0
Evaluation of reduction of nocturnal enuresis in children subjected to rapid maxillary expansion by specific questionnaire.

Level of nocturnal enuresis (NE) will be described with the use of a 4-grade scale prepared for the purposes of the examination, that is 4 – a couple of times during the night, 3 – once during the night, 2 – once or a couple of times during the week and 1 – once or a couple of times during the month.
Timepoint [1] 292705 0
Monthly intervals during the first year after treatment (rapid maxillary expansion).
Endpoint of the study at 3 years after treatment (last questionnaire)
Secondary outcome [1] 309528 0
In children from study group A, for the purposes of documenting the effects of rapid maxillary expansion (RME) on the occlussion, control diagnostic models were made after taking the appliance off.
Dental arch width between the first secondary molars is measures with a caliper
Timepoint [1] 309528 0
3 years after rapid maxillary expansion

Eligibility
Key inclusion criteria
1. present NE
2. present maxillary narrowing
3. correct secretion function of kidneys
4. lack of infection of urinary tract as well as URT
5. consent for participation in the research given by the child’s legal guardians,
6. filling in of the initial information survey
7. replying to final questions concerning NE after 3 years
Minimum age
6 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. not meeting any of the inclusion criteria
2. active teeth caries which did not allow for carrying out orthodontic treatment
3. poor oral cavity hygiene,
4. insufficient number of teeth for fixing the appliance,
5. lack of sufficient motivation to cooperation during orthodontic treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6238 0
Poland
State/province [1] 6238 0

Funding & Sponsors
Funding source category [1] 289631 0
Self funded/Unfunded
Name [1] 289631 0
Address [1] 289631 0
Country [1] 289631 0
Primary sponsor type
Individual
Name
Marek Truszel
Address
Indywidualna Praktyka Stomatologiczna
ul. Kolista 64, 43-300 Bielsko-Biala, Poland
Country
Poland
Secondary sponsor category [1] 288317 0
Hospital
Name [1] 288317 0
Chorzowskie Centre of Paediatrics and Oncology (ChCPiO)
Address [1] 288317 0
ul. Wladyslawa Truchana 7, 41-500 Chorzow, Poland
Country [1] 288317 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291432 0
Bioethical Commission of the Silesian Medical University
Ethics committee address [1] 291432 0
ul. Poniatowskiego 15 40-055 Katowice
Ethics committee country [1] 291432 0
Poland
Date submitted for ethics approval [1] 291432 0
Approval date [1] 291432 0
07/06/2006
Ethics approval number [1] 291432 0

Summary
Brief summary
The primary purpose of the study is to evaluate the effect of rapid maxillary expansion on reduction of nocturnal enuresis in children.
Trial website
Trial related presentations / publications
Public notes
Delay of beginnig the trial after bioethical commission approval is due to other trials conducted at that time.

Contacts
Principal investigator
Name 50082 0
Prof Lidia Hyla - Klekot
Address 50082 0
Chorzowskie Centre of Paediatrics and Oncology (ChCPiO)
ul. Wladyslawa Truchana 7, 41-500 Chorzow
Country 50082 0
Poland
Phone 50082 0
+48 32 349 00 00
Fax 50082 0
Email 50082 0
lidiahylaklekot@gmail.com
Contact person for public queries
Name 50083 0
Dr Marek Truszel
Address 50083 0
Chorzowskie Centre of Paediatrics and Oncology (ChCPiO)
ul. Wladyslawa Truchana 7, 41-500 Chorzow
Country 50083 0
Poland
Phone 50083 0
+48 32 349 00 00
Fax 50083 0
Email 50083 0
marek@truszel.pl
Contact person for scientific queries
Name 50084 0
Dr Marek Truszel
Address 50084 0
Chorzowskie Centre of Paediatrics and Oncology (ChCPiO)
ul. Wladyslawa Truchana 7, 41-500 Chorzow
Country 50084 0
Poland
Phone 50084 0
+48 32 349 00 00
Fax 50084 0
Email 50084 0
marek@truszel.pl