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Evaluating an oral and dental hygiene education based on motivational interviewing in patients with fixed orthodontic appliances

Protocol summary

Study aim
Comparison of plaque index and Gingival index before and after the intervention in 12-16 year old patients undergoing orthodontic treatments referred to the orthodontic department of Tehran University of Medical Sciences
Design
Clinical trial phase 2 without control group,non-randomly,no blinding,on 30 patients
Settings and conduct
Participants will receive verbal instructions during a 20-minute motivational interview with a final year dental student,as well as instruction on how to properly brush and floss on the model. Along with personal advice on how plaque forms,the importance of oral health behaviors,caries,gingivitis and ways to control them,as well as nutritional information related to oral health.At the end, a pamphlet containing the material presented is given to patients.For currencies,PI,GI,demographic information and oral health habits(including daily brushing,frequency of floss,frequency of using sweet snacks per day)before and 1 month after the intervention will be recorded.Patients' motivation is strengthened 3 times in 1 month by phone call. Study place:Orthodontics Department,Dental school,Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients referred to the orthodontic department of the School of Dentistry of Tehran University of Medical Sciences, who were in the age range of 12 to16 years, patients participated in the study voluntarily,signing Consent by parents Conditions of absence:had a physical disability,had a systemic or underlying disease witch affect gingiva or teeth or was taking certain medications
Intervention groups
oral hygiene education based on motivational interviewing
Main outcome variables
Brushing at least twice a day;Flossing at least once a day;Sweet snacks less than twice a day;At least 0.4 difference in plaque index;At least 0.5 difference in gingival index; Good/excellent gingival status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201031049204N1
Registration date: 2020-11-02, 1399/08/12
Registration timing: registered_while_recruiting

Last update: 2020-11-02, 1399/08/12
Update count: 0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Shima Ziari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 1058
Email address
shimaziari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating an oral and dental hygiene education based on motivational interviewing in patients with fixed orthodontic appliances
Public title
Evaluating oral and dental hygiene education based on motivational interviewing in Orthodontic.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the orthodontic department of the School of Dentistry of Tehran University of Medical Sciences who were in the age range of 12 to 16 years. Patients participate in the study voluntarily. signing Consent by parents
Exclusion criteria:
They had a physical disability. having systemic or underlying disease witch causing gingival or dental problems taking certain medications
Age
From 12 years old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University Dental School, after Atomic Energy,North Kargar St. Tehran Town
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.042

Health conditions studied

1

Description of health condition studied
patients undergoing fixed orthodontics
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
changing gingival index with a predetermined criterion of 0.5 unit
Timepoint
Registration of gingival index before and 1 month after the intervention
Method of measurement
Examination and registration of clinical index

2

Description
changing of plaque index with a predetermined criterion of 0.4 unit
Timepoint
Registration of plaque index before and 1 month after the intervention
Method of measurement
Examination and registration of clinical index

Secondary outcomes

1

Description
brushing time with a predetermined standard at least twice a day
Timepoint
record the number of brushing times before and 1 month after intervention
Method of measurement
oral health information checklist

2

Description
flossing with a predetermined standard at least twice a day
Timepoint
record the number of flossing before and 1 month after intervention
Method of measurement
oral health information checklist

3

Description
frequent consumption of sweet snacks with a predetermined standard up to twice a day
Timepoint
record the number of using sweet snacks before and 1 month after intervention
Method of measurement
oral health information checklist

4

Description
gingival inflammation status with a predetermined standard well/good.
Timepoint
registration of gingival inflammation status before and 1 month after intervention
Method of measurement
examination and registration of condition

Intervention groups

1

Description
Educational intervention is done in the form of counseling and motivational interview with the patient in the presence of his parents. First, the researcher states the purpose of the consultation and provides information about the causes of gingivitis, how dental plaque forms, and the effect of sugary and acidic foods on caries. Then we talk about the reasons that may affect dental hygiene behaviors. For example, the patient is asked not to delay the time of brushing so that fatigue does not prevent the control of plaque, or be sure to brush each time after the main meals. Apply fluoridated toothpaste, lasting at least two minutes at a time, and after brushing try to simply spit out the water and preferably not rinse the mouth with water. It is recommended that parents monitor their children's brushing. It also explains how oral health control affects the freshness of breathing and improves social relationships and acceptance of others. It is also noted that in the new conditions created by orthodontics in the mouth, the need for increased plaque control should be thoroughly cleaned. The patient is asked to comment and ask questions, positive behaviors are encouraged, identification problems and possible solutions are provided. Then the child is taught to brush and floss first on the model and then inside the mouth. During this stage, the patient follows the steps with the mirror he has, and in the next stage, the patient must repeat what he has learned in front of the mirror . A brochure containing information on how to brush and floss properly is also provided at the end. To motivate and be more effective, the patient is called once a week during the intervention, which is about a month.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Mahdia Gholami
Street address
First Floor, Department of Oral Health and Social Dentistry, School of Dentistry, beside Atomic Energy, North Kargar End, Enghelab Square.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8889 1058
Email
m_gholami@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice President for Research
Street address
Enghelab Square, North Kargar End, Atomic Energy, School of Dentistry, First Floor, Department of Oral Health and Social Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4284
Email
dentistry@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
40
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
Tehran University of Medical Sciences
Full name of responsible person
Shima Ziari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 20, Ostad Nejatollahi St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1598984618
Phone
+98 21 8889 1058
Fax
Email
shimaziari@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdia Gholami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
dental school of Tehran University of Medical Sciences, next to Atomic energy, North Krgar st
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8889 1058
Fax
Email
shimaziari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shima Ziari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 20, Ostad Nejatollahi St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1598984618
Phone
+98 21 8889 1058
Fax
Email
shimaziari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Still under investigation.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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