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Trial registered on ANZCTR


Registration number
ACTRN12611001152910
Ethics application status
Approved
Date submitted
28/10/2011
Date registered
3/11/2011
Date last updated
7/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association between exposure to second-hand smoke and sleep bruxism in children: a randomised control study.
Scientific title
Children with sleep bruxism exposed to second-hand smoke, compared to not exposed children with sleep bruxism, increased their bruxing activity.
Secondary ID [1] 273249 0
Nil
Universal Trial Number (UTN)
U1111-1125-3539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem studied: sleep bruxism in children exposed to second-hand smoke. Subjects were recruited from a school project about the risks of second-hand smoke. Children found with sleep bruxism and exposed to second-hand smoke were included in the study. 279010 0
Condition category
Condition code
Oral and Gastrointestinal 279251 279251 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
Sleep bruxism was analysed in children of group 1 after six-months of not being exposed to second-hand smoke. The smoking members of the families in group 1 were asked not to smoke in the presence of the child for a period of six months. Parents were told prior to study enrolment that they would not be required to quit smoking as part of study participation; rather they would be asked to eliminate children second hand smoke exposure. The study does not include parents who do not smoke. Children with bruxism exposed to second-hand smoke and then not exposed for 6 months ( same children, same families) were compared with a control group of children with bruxism exposed to second-hand smoke for 6 months. Some families selected in group 1 refused to participate in the trial because, despite being informed about the risks of SHS, they reported that they would not have been able to reduce SHS exposure for their children.
Intervention code [1] 269586 0
Prevention
Comparator / control treatment
Control group: Sleep bruxism was analysed in children of group 2 after six-months of exposure to second-hand smoke. No treatment or change in behaviour was performed in this group. This part of the trial was observational. Parents were smokers and did not to change their smoking habits. Families selected in group 2 and participating in the trial were those reporting not being able to reduce children exposure to SHS. Those parents of group 2 who decided to reduce children exposure to SHS did not participate.
Control group
Active

Outcomes
Primary outcome [1] 279832 0
Presence of sleep bruxism as assessed by by the American Sleep Disorders Association
Timepoint [1] 279832 0
Timepoint: at six months after randomisation
Secondary outcome [1] 294531 0
Degree of exposure to second-hand smoke: occasional, low, moderate, heavy. Data were collected by self-reported questionnaire and personal interview. During the interview the interviewer reviewed the answers on the self-reported questionnaire for completeness and internal consistency. Questionnaire are done with both children and parents.
Timepoint [1] 294531 0
Timepoint: at six months after randomisation

Eligibility
Key inclusion criteria
Children from elementary schools.
Minimum age
8 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cleft lip and palate; disability, respiratory disorders; orthodontic and/or orthopaedic treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We selected from the sample of volunteers those children with sleep bruxism and exposed to second-hand smoke. The children with sleep bruxism and exposed to SHS were randomly divided into two groups. The allocation sequence was concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque and sealed envelopes. In order to prevent subversion of the allocation sequence, the name and date of birth of the participant was written on the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Computer-generated random numbers were used to assign patients to the 2 treatment arms within each stratum.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 3918 0
Italy
State/province [1] 3918 0

Funding & Sponsors
Funding source category [1] 270076 0
Self funded/Unfunded
Name [1] 270076 0
Address [1] 270076 0
Country [1] 270076 0
Primary sponsor type
Individual
Name
Luisa Montaldo
Address
Via De Crecchio
80131
Naples.
Country
Italy
Secondary sponsor category [1] 269083 0
None
Name [1] 269083 0
Address [1] 269083 0
Country [1] 269083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272075 0
Comitato etico seconda universita di napoli
Ethics committee address [1] 272075 0
Via Costantinopoli
80138
NAPOLI
Ethics committee country [1] 272075 0
Italy
Date submitted for ethics approval [1] 272075 0
05/10/2009
Approval date [1] 272075 0
16/11/2009
Ethics approval number [1] 272075 0
2009-013663-26

Summary
Brief summary
The goal of this study was to investigate the association between second hand smoke exposure and sleep bruxism in children. Nicotine is known to induce acetylcholine and glutamate synaptic transmission and enhance dopamine release. In smokers, nicotine accumulates in the body during the time spent awake, decreasing gradually during sleep. Higher levels of smoking, leading to increased levels of nicotine and dopamine release, could thus be related to increased oromotor activity.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 33292 0
Address 33292 0
Country 33292 0
Phone 33292 0
Fax 33292 0
Email 33292 0
Contact person for public queries
Name 16539 0
Pasquale Esposito
Address 16539 0
Pzza garibaldi
Country 16539 0
Italy
Phone 16539 0
+393333794889
Fax 16539 0
Email 16539 0
espositop@hotmail.it
Contact person for scientific queries
Name 7467 0
Luisa Montaldo
Address 7467 0
via de crecchio
80131
Napoli
italy
Country 7467 0
Italy
Phone 7467 0
+393483523825
Fax 7467 0
Email 7467 0
lmontaldo@libero.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary