The objective of this study is to evaluate the impact of an oral health education program on plaque and gingival bleeding indices among mentally disabled children.
The study is a clinical trial, phase II.
Target population: Female mentally disabled students of a special school in Tehran, aged 6 to 17 years old.
Inclusion criteria: All the mentally disabled children aged 6 to 17 years old who can sit down on a chair to be examined and her parents had filled informed consent.
Exclusion criteria: Those who are absent on the follow up examination.
Minimum sample size was calculated 26 units, because of the total number of students of this school 51 students will enter the study.
Intervention: Parents will attend an oral health educational session and a simpler educational recommendations will be said to disabled students. A colorful booklet which was written for students and parents will be sent to their home, motivational reminders and short message sending to parents are also planned, at least every 2 weeks.
Oral examinations on Plaque Index and Gingival Bleeding Index will be done on baseline and 3-month follows up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091915806N7
Registration date:2016-12-22, 1395/10/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-22, 1395/10/02
Registrant information
Name
Ahmad Jafari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
ajafari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of an educational intervention on Plaque Index and Gingival Bleeding Index in mentally disabled school children
Public title
Effect of an oral health education on oral health condition of disabled children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 6 to 17 years old; Mentally disabled; Child can sit down on a chair to be examined; Her parents had filled an informed consent.
Exclusion criteria: Absence on follow up examination.
Age
From 6 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Committee of Ethics in Research, Medicine Faculty, Poursina Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2015-10-07, 1394/07/15
Ethics committee reference number
IR.TUMS.REC.1394.889
Health conditions studied
1
Description of health condition studied
Dental Examination
ICD-10 code
Z01.2
ICD-10 code description
Dental examination
2
Description of health condition studied
Gingivitis and Periodontal Diseases
ICD-10 code
K05
ICD-10 code description
Gingivitis and Periodontal Diseases
3
Description of health condition studied
Calculus and Plaque
ICD-10 code
K03.6
ICD-10 code description
Deposits [accretions] on teeth
Primary outcomes
1
Description
Plaque Index
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Oral and dental examination
2
Description
Gingival bleeding Index
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Oral and dental examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Parents will attend an oral health educational session. A simpler educational recommendations will be said to disabled students. A colorful booklet which was written for students and parents will be gifted to them. Motivational reminders and short message sending to parents are also planned, at least every 2 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Special School of Milad
Full name of responsible person
Mrs. Arabi
Street address
Special School of Milad, After Madrese bus station, Moallem Blvd., Yaft Abad Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Office of Research Affairs
Street address
Office of Research Affairs, 2nd Floor, Dentistry Faculty, AmirAbad Ave., Tehran, Iran
City
Tehran
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
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ahmad Jafari
Position
Associate Professor, Department of Pediatric Dentistry, School of Dentistry, Alborz University of Me
Other areas of specialty/work
Street address
School of Dentistry, Sh. Katooeizadeh St., 45 M Golshahr Blvd., Karaj, Iran
City
Karaj
Postal code
Phone
+98 26 3353 1614
Fax
Email
ajafari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ahmad Jafari
Position
Associate Professor, Department of Pediatric Dentistry, School of Dentistry, Alborz University of Me
Other areas of specialty/work
Street address
School of Dentistry, Sh. Katooeizadeh St., 45 M Golshahr Blvd., Karaj, Iran