Protocol summary

Study aim
Comparison of the effect of two oral health education methods, oral and using video, in terms of changes in plaque index and gum index in patients with gum disease.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized. Randomization is done by an independent person using the sealed envelope program to allocate people equally and randomly in the control and test groups.
Settings and conduct
All the patients referred to the International School of Dentistry, Tehran. Information on plaque index and gingival index of patients before and after phase one periodontal treatment is recorded. People are blindly and randomly placed into two control and test groups. In the control group, oral hygiene education is given face-to-face, which includes demonstration, and in the test group, oral hygiene education is done using video, which is taught the same content in both test and control groups. In the 4-week follow-up, in order to blind the results (outcome blinding), one of the professors who did not monitor the treatment stages of the patient, compares the relevant treatment group in terms of the effectiveness of the educational method.
Participants/Inclusion and exclusion criteria
Eligibility criteria - Minimum average PI and GI with a score of two - Adults over 18 years old - Absence of systemic disease - Presence of at least 20 permanent teeth exclusion criteria - Pregnancy and smoking - Physical and mental problems
Intervention groups
In the control group, oral hygiene education is given face-to-face, which includes demonstrations, and in the test group, oral hygiene education is done using video. In both the test and control groups, the same content is taught.
Main outcome variables
Plaque Index = Quigley Hein Plaque Index gingival index=Silness and loe gingival index Examining these two indicators in health education by video and oral methods

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240626062257N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: registered_while_recruiting

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Zahra Saadat nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 4945
Email address
zahrasaadat13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-08-26, 1403/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of two oral hygiene educational methods, oral and using video, in patients with gingivitis in terms of changes in plaque index and gingival index, a randomized clinical trial
Public title
Comparison of the effectiveness of two oral hygiene educational methods, oral and using video, in patients with gingivitis in terms of changes in plaque index and gingival index
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of gingivitis caused by microbial biofilm in a generalized form Minimum average of PI and GI with a score of two Adults over 18 years old Absence of systemic disease Permanent dentition No history of periodontal disease The presence of at least 20 permanent teeth (which must include teeth 16, 12, 24, 36, 32, 44)
Exclusion criteria:
pregnancy cigarettes Long-term use of drugs affecting the periodontium (corticosteroids, epilepsy drugs, blood pressure drugs, etc.) Physical and mental problems that prevent proper hygiene. Agenesis dental problems Lack of proficiency in Persian language Failure to accept oral hygiene orders
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
People are blinded and randomized in two control and test groups. Matching of two control and test groups is done by frequency matching method, also regression model is used to eliminate the effect of potential confounding variables in the study. Blinding is done with the help of pre-prepared letters. Each letter determines an oral teaching method (control group) or with the help of video (test group). Sequence generation This process is done by an independent person using the sealed envelope program to allocate people equally and randomly in control and test groups. Concealment The obtained codes are printed on a paper inside the letter and arranged in a box in the periodontics department according to the same algorithm (without the students and professors knowing the order). Letters are kept separately after use.
Blinding (investigator's opinion)
Double blinded
Blinding description
The obtained codes are printed on a paper inside the letter and arranged in a box in the periodontics department according to the same algorithm (without the students and professors knowing the order). Letters are kept separately after use.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences
Street address
No 7, Mahshid Alley, Mehrdad Alley, Fakhrizadeh St., Noboniyad, Tehran Town
City
Tehran
Province
Tehran
Postal code
1693718184
Approval date
2024-05-19, 1403/02/30
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1403.028

Health conditions studied

1

Description of health condition studied
gingivitis
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Quigley-Hein plaque index and Silness and Loe gingival index are compared in both video and oral methods.
Timepoint
The indicators are measured before the treatment and then 4 weeks after the treatment.
Method of measurement
Plaque and gingival inflammation are measured using Quigley-Hein plaque index and Silness and Loe gingival index.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oral hygiene training is using video (the training video is posted on www.aparat.com so that patients can access the video and watch it often if necessary). In both test and control groups, the same content is taught, which includes brushing with the rolling technique and medium type toothbrush and the correct way to floss.
Category
Other

2

Description
Control group: In the control group, oral hygiene training is given face-to-face, which includes demonstration. In both the test and control groups, the same content is taught, which includes brushing with the rolling technique and the medium type toothbrush. It is correct to floss.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
International Faculty of Dentistry Faculty of Medical Sciences, Tehran
Full name of responsible person
Amir Raei
Street address
Faculty of Dentistry, International Campus, Mahan Street, Khani Abad No, Nawab Highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Email
dentistyic@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
دانشکده بین الملل دانشکده دندانپزشکی علوم پزشکی تهران
Full name of responsible person
Behrad Tanbakouchi
Street address
Faculty of Dentistry, International Campus, Mahan Street, Khani Abad No, Navab Highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Email
dentistyic@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
دانشکده بین الملل دانشکده دندانپزشکی علوم پزشکی تهران
Proportion provided by this source
10
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
Amir Raei
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, International Campus, Mahan Street, Khani Abad No, Navab Highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Email
amirraee@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Raei
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, International Campus, Mahan Street, Khani Abad No, Navab Highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Email
amirraee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Saadat Nejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, International Campus, Mahan Street, Khani Abad No, Navab Highway, Tehran Town
City
Tehran
Province
Tehran
Postal code
dentistyic@tums.ac.i
Phone
+98 21 5585 1151
Email
zahrasaadat13@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared, such as education, age, gender, amount of plaque and gingivitis.
When the data will become available and for how long
The beginning of the access period is 3 months after the end of the results and conclusions.
To whom data/document is available
The data will be applicable and accessible to all dentists.
Under which criteria data/document could be used
It is allowed to use the documents for further research on the subject or to exploit it.
From where data/document is obtainable
Applicants can contact me via e-mail to receive documents (zahrasaadat13@yahoo.com).
What processes are involved for a request to access data/document
The applicant must be qualified to use the data and must be a dentist.
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