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The effect of texting health guidelines on clinical outcome of scaling & root planning (SRP) in patients with gingivitis

Protocol summary

Study aim
to Determine the effect of providing health instructions via SMS on improving the clinical results of scaling & root planning (SRP)
Design
First, the amount of (BOP) bleeding on probing, (PI) plaque index, Probing Depth (PD), will be recorded for patients. After non-surgical periodontal treatments, in the case group, people will be given text messages containing health information 4 times a week for 1 month. Patients are then called and re-examined for BOP, PD, PI.
Settings and conduct
In this one-blind clinical trial with control group, randomized, phase 3, 36 patients with gingivitis referred to the periodontics department of Shahid Sadoughi Dental School of Yazd are selected. Randomization of this study as a randomized split half using a table of random numbers done with Random Allocation software.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: patients over 18 years of age, being systemically healthy, having access to a mobile phone, not having undergone periodontal treatment in the last 6 months, and not taking antibiotics. Pregnant patients, those who smoke and people with diabetes will be excluded from the study.
Intervention groups
For all patients, non-surgical periodontal treatment will be performed and then only in the case group, people will be given text messages containing health information 4 times a week for 1 month.
Main outcome variables
Probing depth, bleeding on probing, plaque index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171015036782N8
Registration date: 2022-01-22, 1400/11/02
Registration timing: registered_while_recruiting

Last update: 2022-01-22, 1400/11/02
Update count: 0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
farzane vaziri
Name of organization / entity
Shahid sadoughi dental university
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 4764
Email address
f.vaziri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of texting health guidelines on clinical outcome of scaling & root planning (SRP) in patients with gingivitis
Public title
The effect of texting health guidelines on clinical outcome of scaling & root planning (SRP) in patients with gingivitis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Systematically healthy have access to a cell phone have not had periodontal treatment in the last 6 months, and do not take antibiotics
Exclusion criteria:
pregnancy smoker diabetic patient
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
For each patient with gingivitis who has referred to the period ward of the dental school for periodontal treatment and the necessary inclusion conditions, including systemic health, no pregnancy, no smoking, no antibiotics and receiving periodontal treatment in the last 6 months Define a code and we will enter these codes in Random Allocation Software 2.0. Then, using software, we randomly select 36 codes in two groups of 18 to enter the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.SSU.REC.1400.077

Health conditions studied

1

Description of health condition studied
gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced

Primary outcomes

1

Description
Probing depth
Timepoint
Beggining of study and 1 month later
Method of measurement
Williams probe

2

Description
Bleeding on probing
Timepoint
Beggining of study and 1 month later
Method of measurement
by observation of Bleeding on probing in the mouth and measuring its percentage

3

Description
plaque index
Timepoint
Beggining of study and 6 week later
Method of measurement
observation of plaque

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: non-surgical periodontal treatment and then send text messages containing health information to individuals, 4 times a week for 1 month
Category
Behavior

2

Description
Control group: non-surgical periodontal treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Milad eidy
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
miladeidy1372@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mostafa mahmoodi
Street address
Shahid Sadoughi Faculty of Dentistry Yazd, Emam Reza Square
City
Yazd
Province
Yazd
Postal code
8915839985
Phone
+98 35 3621 2623
Email
miladeidy1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
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
Yazd University of Medical Sciences
Full name of responsible person
Milad eidy
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
miladeidy1372@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Milad eidy
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
miladeidy1372@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Milad eidy
Position
Post graduation
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.2,Second Alley, East touba Ave, Amirkabir Blvd ,Yazd
City
Yazd
Province
Yazd
Postal code
8916147860
Phone
+98 35 3830 1323
Email
miladeidy1372@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
The whole data is shared
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Email, Call
From where data/document is obtainable
milad eidy.09919635479, miladeidy1372@gmail.com
What processes are involved for a request to access data/document
After sending the Email, the data will be transmitted
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