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Comparative evaluation of virtual versus verbal oral hygiene instructions on periodontal indices in patients with fixed orthodontic appliances

Protocol summary

Study aim
Effectiveness of virtual versus verbal oral hygiene instructions on periodontal indices in patients with fixed orthodontic appliances
Design
This research is a single-blind, parallel, randomized prospective clinical trial. Study sample is determined through repeated measures design. Considering 4 repetitions, correlation of 0.50, 95% confidence interval and significance level of 0.05, we use a variance of 0.020 from a previous studies, sample size in each group was calculated to be at least 23 patients.R package for randomization of clinical trials will be used. This clinical trial is categorized as phase 3.
Settings and conduct
Convenient sampling will be used from those referring to an assigned orthodontic clinic. Patients are randomly assigned into two groups. .Clinical examiner who measures and records the indices in totally blind to the study protocol.
Participants/Inclusion and exclusion criteria
Patients are young adults who are diagnosed to be treated with fixed orthodontic appliances. Educated, non-smokers, having a smart phone with internet access is the primary needs to be included in the study. Having diabetes, immune diseases, taking medication with periodontal side effects, lactating or pregnant women are excluded.
Intervention groups
Participants will be divided in two groups. All the participants will receive a standard oral hygiene instruction in-person at baseline upon starting the treatment. Afterwards, one group will receive oral hygiene instruction recalls in person once a month during routine orthodontic treatment while the other group receive virtual recalls every two weeks for the duration of the study.
Main outcome variables
Primary outcomes include: Dental plaque index, gingival bleeding index, and index of gingival inflammation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080824001081N9
Registration date: 2019-12-23, 1398/10/02
Registration timing: registered_while_recruiting

Last update: 2019-12-23, 1398/10/02
Update count: 0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of virtual versus verbal oral hygiene instructions on periodontal indices in patients with fixed orthodontic appliances
Public title
Effectiveness of virtual oral hygiene instruction on periodontal health in fixed orthodontic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in need for fixed orthodontic treatment including first molar teeth. Ability to write and read Having a smart phone with daily access to the internet Agreement upon signing an informed consent
Exclusion criteria:
Taking any anti-inflammatory and/or antibiotic medication during past three months Receiving any periodontal treatment during past 6 months Diabetes Cigarette smoking Inflammatory joint diseases Pregnancy and/or lactation Taking immunosuppressive medication during past 3 months Mouth breathing with inadequate lip closure Taking medications with periodontal side effects such as, Nifedipine, Cyclosporine, Phenytoin, Dilantin Any nutritional disorders
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize R package for clinical trials.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the clinical examiner who evaluates and records the periodontal indices at baseline, 1 and 3 months post intervention is blinded to the case and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Dental Faculty of Guilan University of Medical Sciences, Fuman-Saravan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Approval date
2019-12-05, 1398/09/14
Ethics committee reference number
IR.GUMS.REC.1398.418

Health conditions studied

1

Description of health condition studied
Chronic plaque-induced gingival inflammation
ICD-10 code
K05.10
ICD-10 code description
ژنژیویت مزمن مارجینال ساده

2

Description of health condition studied
dental plaque
ICD-10 code
K03.6
ICD-10 code description
Deposits [accretions] on teeth

Primary outcomes

1

Description
plaque index
Timepoint
Baseline, one and three months post-intervention
Method of measurement
Plaque index, Silness and Loe

2

Description
Gingival inflammation
Timepoint
Baseline, one and three months post-intervention
Method of measurement
Modified gingival index, Loe and Silness

3

Description
Gingival bleeding index
Timepoint
Baseline, one and three months post-intervention
Method of measurement
Gingival bleeding index, Lenox and Kopczyk

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients receive standard oral hygiene instructions in the clinic which include Modified Bass brushing technique, dental flossing and use of interdental brushes. Instructions will be given to the patients at baseline (before orthodontic treatment), and repeated every month for 3 months after initiation of orthodontic treatment.
Category
Prevention

2

Description
Intervention group:Patients receive standard oral hygiene instructions in the clinic and in-person only at baseline (before starting orthodontic treatment) which include Modified Bass brushing technique, dental flossing and use of interdental brushes. After initiation of orthodontic treatment, instructions will be given to the patients every two weeks for the following three months through videos using the WhatsApp installed on the patients' smart phones.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of orthodontics, Faculty of Dentistry, Guilan University of Medical Sciences
Full name of responsible person
Parvaneh Abbaspoor Mozhdehi
Street address
Gilan University of Medical Sciences, Fuman-Saravan highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
dental@gums.ac.ir
Web page address
http://www.gums.ac.ir/dental

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naghipoor
Street address
6th floor, central building of the Gilan University of Medical Sciences, opposite Azodi stadium, Namjoo Street
City
Rasht
Province
Guilan
Postal code
41446-56513
Phone
+98 13 3322 9599
Fax
+98 13 3332 2444
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
researchers
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr, Golpar Radafshar
Position
Associate professor of Periodontology, Department of Periodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fuman-Lakan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
golishad@gmail.com
Web page address
http://www.gums.ac.ir/dental

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Golpar Radafshar
Position
Associate Professor of Periodontology, Department of Periodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fuman-Saravan Highway
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
golshad@gums.ac.ir
Web page address
http://www.gums.ac.ir/dental

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parvaneh Abbaspoor Mozhdehi
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Fuman-Saravan Highwat
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3348 6406
Email
parvanehmojdehi22@gmail.com
Web page address
http://www.gums.ac.ir/dental/Default.aspx?tabid=902

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
Participants do not consent that their data get published.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
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
Since we intend to publish an article based on the present research, the only available data is through the potential article.
When the data will become available and for how long
Within the next 6-8 months the article will get ready for submission and an exact date of publication is not predictable since it depends on the assigned journal policy,
To whom data/document is available
Researchers intend to publish the article in an open access journal so all the stakeholders and interested professionals will be able to access to the content.
Under which criteria data/document could be used
This research will be published in line with the international and national goal for improving dental and periodontal hygiene instruction among young adults.
From where data/document is obtainable
Searching the article key words in any search engine would guide the interested people to the article.
What processes are involved for a request to access data/document
No particular process will not be necessary.
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