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Comparative evaluation of effectiveness of two toothpastes containing potassium nitrate in the treatment of dentinal hypersensitivity secondary to scaling and root planing

Protocol summary

Study aim
Comparison of the effectiveness of two types of toothpaste containing potassium nitrate in the treatment of dental hypersensitivity secondary to SRP
Design
Clinical trial with 2 groups of parallel intervention, double-blind, randomized, phase 3 on 22 patients, our tool is to randomize the table of random numbers, The sample size in each group is 11 people, and a total of 22 people.
Settings and conduct
This study will be carried out in the Periodontics department of Tabriz dental faculty.The two groups will be assimilated based on age and gender. dental hypersensitivity is determined at the beginning of the period, then on the 15th day, and finally on 30th day for each individual. the test consists of a score of 1 to 10 that the patient gives to the sensitivity of the teeth in touch, cold and hot stimulants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 20-50 years, patients undergoing scaling treatment, presence of at least 3 sensitive teeth, exclusion criteria: allergy to the contents of toothpaste, generalized pathology in oral cavity, sensitive teeth with mobility higher than grade1, sensitive teeth suspected to pulpitis, enamel crack or caries, people taking anti epileptic, antihistamine, antidepressant, pregnant and lactating women
Intervention groups
Intervention group 1: Meridant toothpaste recipients to reduce tooth sensitivity following scaling and root planning (SRP) Intervention group 2: Pronamel toothpaste recipients to reduce tooth sensitivity following SRP
Main outcome variables
The amount of pain relative to cold, heat and touch stimuli,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100412003690N12
Registration date: 2020-08-26, 1399/06/05
Registration timing: retrospective

Last update: 2020-08-26, 1399/06/05
Update count: 0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Masoomeh Faramarzie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 4863
Email address
faramarzim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effectiveness of two toothpastes containing potassium nitrate in the treatment of dentinal hypersensitivity secondary to scaling and root planing
Public title
Comparison of the effect of two different toothpastes in the treatment of dental hypersensitivity secondary to scaling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient underwent scaling and Root Planning The presence of at least 3 teeth with dental hypersensitivity
Exclusion criteria:
History of allergy to toothpaste Compounds extensive pathology in the oral cavity Chronic systemic disease Teeth with tooth sensitivity with more than first degree mobility, teeth with extensive restoration or defect or with prosthetic coating, teeth suspected of pulpitis or with enamel cracking or caries Pregnant and lactating women Participants in the study were treated similarly to those who received any dental anti-sensitivity products last month
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of toothpaste to patients will be done randomly in such a way that the third person will pre-codify the toothpaste and distribute it in the same size plastic containers with code A or B and without any other markings. The type of toothpaste will be specified with the codes A (Iranian) and B (foreign) and placed inside the sealed envelopes, then the envelopes will be placed in a bag and shaken. Then it is randomly taken out of the bag and after observing the toothpaste code, it will be given to the patient. None of the patients are informed about the other patient's toothpaste
Blinding (investigator's opinion)
Double blinded
Blinding description
The toothpaste will be placed by an third person in unmarked plastic containers and will be marked with codes A and B for each type of toothpaste. The allocation of toothpaste to patients will be by a third person so the patient and the evaluator of tooth hypersensitivity will not be aware of the type of toothpaste.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.TBZMED.REC.1399.441

Health conditions studied

1

Description of health condition studied
Dental Hypersensitivity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The intensity of pain in response to cold, heat and touch stimulants
Timepoint
In the first visit, 15 days later and finally on the 30th day
Method of measurement
Using Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: those who receive Merident desensitizing toothpaste, product of Pakshu company, which contains potassium nitrate; the toothpaste will be applied topically. to do this, the sensitive teeth will be covered for 2 minutes; at least 2 times a day for 1 month with the toothpaste after placing it on the toothbrush.
Category
Treatment - Drugs

2

Description
Intervention group 2: those who receive Pronamel desensitizing toothpaste, product of Sensodyne company, which contains potassium nitrate; the toothpaste will be applied topically. to do this, the sensitive teeth will be covered for 2 minutes; at least 2 times a day for 1 month with the toothpaste after placing it on the toothbrush.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
Full name of responsible person
Masoomeh Faramarzi
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Faramarzim@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 1334 6977
Email
Faramarzim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iran, Tabriz, Golgasht St., Tabriz University of Medical Sciences, School of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1385 4863
Fax
+98 41 1334 6977
Email
Faramarzim@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Tabriz University of Medical sciences, Golgasht Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1385 4863
Fax
+98 41 1334 6977
Email
Faramarzim@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iran, Tabriz, Golgasht St., Tabriz University of Medical Sciences, School of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1385 4863
Fax
+98 41 1334 6977
Email
Faramazim@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
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