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Comparison the effect of Sodium fluoride in the form of hydrogel in reducing root sensitivity after periodontal flap surgery

Protocol summary

Study aim
The effect of Sodium fluoride in the form of hydrogel in reducing root sensitivity after periodontal flap surgery
Design
This randomized clinical trial is a double-blinded study with a parallel design. This double-blinded study, randomized study, phases 2-3, will be conducted on 36 patients. A table of random numbers is used for randomization, and the participants are assigned to three intervention groups.
Settings and conduct
In this double-blind study, which will be conducted in the specialized periodontology department of Azad University of Isfahan, Khorasgan branch, the clinical caregiver and the patient are unaware of who will receive the new drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Systemically healthy patients with severe chronic generalized periodontitis with probing depth ≥ 5 mm; Radiographic evidence includes supraosseous horizontal bone loss Exclusion criteria:Patients currently undergoing DH treatment; Patients with chronic systemic diseases and nerves; pregnant women;breastfeeding mothers
Intervention groups
In the first intervention group, a small brush is dipped in sodium fluoride solution and used on the buccal surfaces of the root, then sutured. In the second intervention group, 3 cc of hydrogel form in the form of pluronic acid f127 to provide mechanical properties and easy exit from the syringe at 37 degrees, and Kropel p 934 to create a hydrogen bond with the tooth and sodium fluoride were used before suturing. In the third intervention group, before suturing, a small brush is immersed in normal saline solution and used on the buccal surfaces of the roots.
Main outcome variables
Sensitivity to touch test, sensitivity to heat, sensitivity to cold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N190
Registration date: 2022-12-09, 1401/09/18
Registration timing: prospective

Last update: 2022-12-09, 1401/09/18
Update count: 0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Sodium fluoride in the form of hydrogel in reducing root sensitivity after periodontal flap surgery
Public title
Comparison the effect of Sodium fluoride in reducing root sensitivity after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Systemically healthy patients with severe chronic generalized periodontitis with probing depth ≥ 5 mm Radiographic evidence includes supraosseous horizontal bone loss
Exclusion criteria:
Patients currently undergoing DH treatment Patients with chronic systemic diseases and nerves pregnant women Patients with eating disorders and digestive disorders History of tooth cracking, root canal treatment, chipped teeth, abrasion, faulty restorations, orthodontic devices, fixed prosthesis, artificial teeth Deep caries lesions and periodontal surgery in the last 6 months Patients with less than 6 teeth
Age
From 40 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method. Numbers 1 to 36 are written on 36 cards. The 12 numbers that are randomly selected in the first stage are assigned to the first group. The 12 numbers that are randomly selected in the second stage are assigned to the second group, and the 12 numbers that are randomly selected in the third stage are assigned to the third group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are informed about participating in the study and receiving the new drug, but the clinical caregiver and the participant will be kept blind to what type of drug each group will receive. Medicines can only be identified through the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2022-11-06, 1401/08/15
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.239

Health conditions studied

1

Description of health condition studied
Flap surgery
ICD-10 code
K05.5
ICD-10 code description
Other periodontal diseases

Primary outcomes

1

Description
Sensitivity to touch test
Timepoint
1st, 2nd, 4th and 6th week after periodontal surgery
Method of measurement
Using a sharp probe

2

Description
Sensitivity to heat test
Timepoint
1st, 2nd, 4th and 6th week after periodontal surgery
Method of measurement
Using gutta-percha

3

Description
Sensitivity to cold
Timepoint
1st, 2nd, 4th and 6th week after periodontal surgery
Method of measurement
Using cold spray

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group, a small brush is dipped in sodium fluoride solution and used on the buccal surfaces of the root, then sutured.
Category
Treatment - Other

2

Description
In the second intervention group, 3 cc of hydrogel form in the form of pluronic acid f127 to provide mechanical properties and easy exit from the syringe at 37 degrees, and Kropel p 934 to create a hydrogen bond with the tooth and sodium fluoride were used before suturing
Category
Treatment - Other

3

Description
. In the third intervention group, before suturing, a small brush is immersed in normal saline solution and used on the buccal surfaces of the roots.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Azad University Dental Faculty
Full name of responsible person
Vahedeh Sharifi
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
Vahide.sharifi1996@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Vahedeh Sharifi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Jay Street, street of shohaday Abr
City
Isfahan
Province
Kermanshah
Postal code
8155139998
Phone
+98 31 3535 4001
Email
Vahide.sharifi1996@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Rafiei
Position
Faculty member of Isfahan University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Jay Street, street of shohaday Abr
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
dr_ehsan6@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vahedeh Sharifi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Jay Street, street of shohaday Abr
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
Vahide.sharifi1996@gmail.com

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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