Protocol summary

Summary
Objectives: determination of the effect of five oral hygiene teaching method in patients with orthodontic appliances. The study population: patients with fixed orthodontic appliances (age range 12 -25 years old) referred to two specialist orthodontic offices located in Hamadan. Design: randomized, single-blind, multicenter. Inclusion criteria: patient should be started their fixed orthodontic treatment during previous 3 months, and no special oral health education at the time of orthodontic treatment, is never given. Patients should have no systemic disease that affect their periodontal conditions; like Diabetes. Also patients must have normal levels of psychological and learning. Exclusion criteria: lack of patient cooperation in principles of education and failure to follow up referral appointment. Target sample size: 125. Setting and conduct: The first group receive orthodontic oral hygiene instruction in the form of face to face training, the second group in the form of face to face training with pamphlet, the third group in the form of face to face training with videotape, the fourth group in the form of face to face training with use of disclosing agent, The fifth group in the form of pamphlet and use of disclosing agent, receive oral hygiene instruction. Time of intervention: one week later orthodontic appliance installation, plaque Index and gingival index will be recorded and oral hygiene instruction will be presented. A week later oral hygiene instruction and one month later oral hygiene instruction, plaque Index and gingival Index will be recorded again. Main outcome measure: plaque Index, gingival Index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120915726N1
Registration date: 2013-12-20, 1392/09/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Mojgan Taheri
Name of organization / entity
Hamadan University of Medical Sciences, Faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 4016
Email address
m.taheri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of five oral hygiene teaching method in patients with orthodontic appliances (A comparative evaluation)
Public title
The effect of five oral hygiene teaching method in patients with orthodontic appliances (A comparative evaluation)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patient should be started their fixed orthodontic treatment during previous 3 months, and no special oral health education at the time of orthodontic treatment, is never given. Patients should have no systemic disease that affect their periodontal conditions; like Diabetes. Also patients must have normal levels of psychological and learning. Exclusion criteria: lack of patient cooperation in principles of education and failure to follow up referral appointment.
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 125
Randomization (investigator's opinion)
Randomized
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2013-05-01, 1392/02/11
Ethics committee reference number
16/35/9/276/پ/د

Health conditions studied

1

Description of health condition studied
Gingivitis
ICD-10 code
k05.1
ICD-10 code description
Chronic gingivitis

Primary outcomes

1

Description
Plaque Index
Timepoint
Beginning of the study befor oral hygiene instruction, A week later oral hygiene instruction, One month later oral hygiene instruction
Method of measurement
By use of Disclosing Agents Basad on Green & Vermillion Plaque Index

2

Description
Gingival Index
Timepoint
Beginning of the study befor oral hygiene instruction, A week later oral hygiene instruction, One month later oral hygiene instruction
Method of measurement
By WHO periodental prob Based on Silness-Löe Gingival Index

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 30 minute face to face oral hygiene instruction, one week later orthodontic appliance installation
Category
Prevention

2

Description
Intervention group 1: 30 minute face to face oral hygiene instruction with Pamphlet, one week later orthodontic appliance installation
Category
Prevention

3

Description
Intervention group 2: 30 minute face to face oral hygiene instruction with videotape , one week later orthodontic appliance installation
Category
Prevention

4

Description
Intervention group 3: 30 minute face to face oral hygiene instruction with use of Disclosing agent , one week later orthodontic appliance installation
Category
Prevention

5

Description
Intervention group 4: oral hygiene instruction with Pamphlet and use of Disclosing agent , one week later orthodontic appliance installation
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mohammad Karim Soltani doctor's office
Full name of responsible person
Mohammad Karim Soltani, Orthodontists, Assistant Professor
Street address
No 512, Dead End Shbbo, Befor Hotel BuAli, Sinzdahkhane Street, Hamedan, Iran
City
Hamadan

2

Recruitment center
Name of recruitment center
Farhad Jafari Doctor's Office
Full name of responsible person
Farhad Jafari, Orthodontists, Assistant Professor
Street address
Building Moshaver, Khaje Rashid Street,Tomb of Buali Square, Hamedan, Iran
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Heidar Tavilani
Street address
Vice chancellor for research, Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamedan 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
Hamadan faculty of dentistry
Full name of responsible person
Mojgan Taheri
Position
General Dentist
Other areas of specialty/work
Street address
No. 1, Alley Rezvan 4, Shahrak Modarres, Hamadan, Iran.
City
Hamadan
Postal code
6517816563
Phone
+98 81 1829 1439
Fax
+98 81 1829 1439
Email
taheri.mojgan.86@gmail.com; m.taheri@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan faculty of dentistry
Full name of responsible person
Mohammad Karim Soltani
Position
Orthodontic
Other areas of specialty/work
Street address
Department of Orthodontics, Faculty of dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan, Iran
City
Hamadan
Postal code
6517838677
Phone
+98 81 1835 4016
Fax
+98 81 1835 4016
Email
MKSoltani2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan faculty of dentistry
Full name of responsible person
Mojgan Taheri
Position
General dentist
Other areas of specialty/work
Street address
No. 1, Alley Rezvan 4, Shahrak Modarres, Hamadan, Iran.
City
Hamadan
Postal code
6517816563
Phone
+98 81 1829 1439
Fax
+98 81 1829 1439
Email
taheri.mojgan.86@gmail.com; m.taheri@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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