The effect of Cognitive Behavioral Therapy on the dental plaque index of adolescents with bipolar mood disorder
Design
A clinical trial with parallel intervention group, single-blind, randomized, on 60 patients. The sampling method is random. Randomization is done using a table of random numbers.
Settings and conduct
Among the patients with youth bipolar mood disorder who are in the final stages of hospitalization and whose symptoms are in the phase of relative subsidence and who have the necessary cooperation, and from the child and adolescent department of Razi Hospital in Tabriz or from the child and adolescent psychiatry subspecialty clinics. With accessible sampling, they will be selected based on DSM-5 criteria, with the diagnosis of child and adolescent psychiatry subspecialist, and with the use of K-SADS semi-structured interview. At first, the participants in this study will be examined by a dentist, and their dental plaque index will be measured and recorded using a disclosing solution. Patients are randomly assigned to one of the groups. In the intervention group, they will participate in 8 face-to-face oral hygiene training sessions with cognitive-behavioral therapy techniques. One month after the sessions, they will be examined by a dentist who is unaware of the groupings, and their index plates will be recorded and evaluated. There is no intervention in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: physically able to perform health measures, IQ above 70 (measured with the Raven test), having at least 20 teeth
Exclusion criteria: Absence in any of the CBT sessions, presence of the orthodontic appliance
Intervention groups
Intervention: oral health education with cognitive-behavioral therapy technique
Control: no intervention
Main outcome variables
Dental plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230418057951N1
Registration date:2023-04-30, 1402/02/10
Registration timing:registered_while_recruiting
Last update:2023-04-30, 1402/02/10
Update count:0
Registration date
2023-04-30, 1402/02/10
Registrant information
Name
Amirreza Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 681 2094
Email address
amirreza.dehghani97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-25, 1402/02/05
Expected recruitment end date
2023-05-25, 1402/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cognitive Behavioral Therapy on the dental plaque index of adolescents with bipolar mood disorder
Public title
The effect of oral hygiene education in adolescents with bipolar mood disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents aged 12 to 18 with bipolar disorder
Having written informed consent from the parent or legal guardian (consent) and oral consent from the participating adolescent (oral assent)
Exclusion criteria:
Suffering from major psychiatric and other physical diseases
Presence of congenital genetic disorder
Use of anticholinergic drugs
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling will be done among the children and adolescents referred to Tabriz Razi Hospital or from the child and adolescent psychiatry clinics of Tabriz University of Medical Sciences who are eligible for the study. The randomization method is simple and its unit is individual. Our tool for randomizing a table of random numbers. Based on this, the type of treatment is marked with code A (oral health education with cognitive-behavioral therapy technique) and B (control) and placed inside the sealed envelopes. Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. The researcher who has to enter the data into the checklist will not know the type of group the person is in.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blind. The researcher who has to enter the data into the checklist will not know about the type of group that the person is in.
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
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.TBZMED.REC.1401.1088
Health conditions studied
1
Description of health condition studied
Dental plaque
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Dental Plaque
Timepoint
One month after the end of the sessions
Method of measurement
People will be examined by a dentist and training on dentistry will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People will be examined by a dentist and training on the dentic will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. A week after the training session on the dentic, people will be called again and examined by a dentist, and their dental plaque index will be evaluated and recorded, and health education will be repeated if needed. Then the participants will be randomly divided into case and control groups. People in the intervention group will participate in 8 in-person oral hygiene training sessions with cognitive-behavioral therapy techniques. At the end of each session, assignments are given to these people and will be reviewed at the beginning of the next session. One month after the sessions, they will be examined by a dentist who is unaware of the groupings, and their index plates will be recorded and evaluated.
Category
Other
2
Description
Control group: People will be examined by a dentist and training on the dentic will be shown in a practical way, and participants will practice the taught materials on dentistry. Then, the disclosing solution is contacted with all the dental surfaces for 30 seconds, and after washing the mouth, it is checked using a mirror and probe under the light of the unit, and the number of colored surfaces is calculated in relation to the total dental surfaces, and the index plate is obtained. A week after the training session on the dentic, people will be called again and examined by a dentist, and their dental plaque index will be evaluated and recorded, and health education will be repeated if needed. Then the participants will be randomly divided into case and control groups. The people of the control group will be called one month later and their index plates will be evaluated and recorded.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Razi Hospital
Full name of responsible person
Amirreza Dehghani
Street address
Elgoli, Razi hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
amirreza.dehghani97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soudabeh Kimiai
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
amirreza.dehghani97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Yasmineh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
yasamineh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Yasmineh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
yasamineh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Yasmineh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
yasamineh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available