Determination and comparison of plaque index in ADHD children receiving methylphenidate before and after the routine oral health training
2. Determination and comparison of plaque index in ADHD children receiving methylphenidate before and after PMT with emphasis on health education
3.comparison of plaque index changes in case and control groups
Design
randomized, parallel, single-blind clinical trial with 36 patients. The simple randomization method has been used for randomization.
Settings and conduct
First, in both groups, the dental plaque index will be measured using a detector solution. Then, the control group will get routine health training and a month later their dental plaque index will be registered by the same dentist. Case group parents will participate in 8, 1-hour PMT sessions at Razi Hospital in Tabriz with an interval of 1 week. Children's dental plaque will be re-evaluated one month after the end of the sessions.
Participants/Inclusion and exclusion criteria
Entry requirements
1.Children in the age range of 6 to 12 years
2. IQ above 70 in children
3. Higher education of parents
4. Cooperation and participation of parents in PMT classes
5. Responsible of patient care
6. Written informed consent
Not entry conditions
1. Existence of major psychiatric pathology in parents
2. Existence of major psychiatric pathology other than ADHD in children.
3. Taking other psychiatric medications by the child
4. Lack of cooperation of the child
Intervention groups
The children will be divided into two groups of case and control. The case group parents will participate in 8 PMT sessions focusing on children's oral health and the control group will get routine health training such as the correct method of rolling brushing technique.
Main outcome variables
The main consequence is the children's plaque index, which will be measured by the detector solution before and after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052251N1
Registration date:2021-10-18, 1400/07/26
Registration timing:registered_while_recruiting
Last update:2021-10-18, 1400/07/26
Update count:0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Neda Yasamineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 4991
Email address
yasamineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-30, 1400/06/08
Expected recruitment end date
2021-12-28, 1400/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of parent management training on dental plaque index in children with attention deficit hyperactivity disorder
Public title
Evaluation of the effectiveness of parent management training on dental plaque index in children with attention deficit hyperactivity disorder
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children in the age range of 6 to 12 years
IQ above 70 children which will be determined by raven test intelligence screening
Higher education level of parents
Cooperation and participation of parents in PMT classes
Being responsible of patient care
Written informed consent
Exclusion criteria:
Existence of major psychopathology in the parent that will be measured through medical records and SCL-90 questionnaire
Existence of major psychiatric pathology other than ADHD in children
Taking other psychiatric medications by the child
Lack of cooperation of the child
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this test, simple randomization will be used. in order to achieve two groups with equal sample size. 36 equal envelopes will be ready and 18 of them will be written group a and 18 of them will be written group b and the envelopes will be compeletly closed. Patients will be randomly assigned to one of these two groups by selecting an envelope. Group a will be the intervention group and group b will be the control.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person examining the children's dental plaque index will not know in which study group the examined people are. Therefore, the study will be one-sided blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.448
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
dental plaque index
Timepoint
Before the intervention and one month after the end of the PMT sessions
Method of measurement
disclosing solution
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Parents of Case group, which is 18 people, in a group with a maximum of twelve people in a hall with sufficient space and appropriate spacing to comply with coronary prevention health protocols in Razi Hospital, Tabriz in 8 1-hour PMT sessions with emphasis on oral health education They will participate with an interval of 1 week. PMT sessions in the form of the first session explaining ADHD, the second session using rewards and points, the third session using induced praise, the fourth session neglecting, the fifth session high-risk behaviors, the sixth session eliminating Rewards and Points The seventh session will be the application of corporal punishment and the eighth session will be the use of surrender, which will be conducted under the supervision of a child and adolescent psychiatrist. 1 month after the end of the sessions, the people will be examined again by the same dentist and their dental plaque index will be evaluated and recorded.
Category
Lifestyle
2
Description
Control group: The control group, which consists of 18 people, will get the routine health training, such as the correct method of the rolling brushing technique, and one month after the end of the sessions, they will be examined by the same dentist and their dental plaque index will be evaluated and recorded.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Tabriz and specialized child and adolescent psychiatric clinics
Full name of responsible person
Gholamreza Nourazar
Street address
Bakeri Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
s.gh.noorazar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samii
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3177 1041
Email
info@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?