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Evaluation and comparison of the effects of a new paste containing 8% L-Arginine and CaCO3 plus KNO3 on dentinal tubules occlusion and dental sensitivity: a randomized, triangular blinded clinical trial study

Protocol summary

Study aim
Evaluation of the effect of a new paste containing L-arginine/calcium carbonate 8% and potassium nitrate on the occlusion of dentinal tubules and tooth sensitivity
Design
A clinical trial with a control group, with parallel groups, triple-blind, randomized, phase 3 on 16 patients. For randomization, manual drawing with sealed envelopes was used.
Settings and conduct
This study is conducted in the restorative department of Mashhad Dental School, and the application process is done by one person and the sensitivity assessment is done by another person who is not aware of the type of treatment for each half to blind the patient, evaluator and statistician. To evaluate the sensitivity to cold and touch, a 1 cm air puff was used for 3 seconds and the movement of a probe in the CEJ area were used, respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Patients in need of dental desensitization treatment, in such a way that the teeth that need to be desensitized are free of decay or restoration. • Patients with an age range of 18 to 50 years • Patients in good general and oral health conditions • Not having a history of illness or long-term drug use • People who do not use orthodontic appliances Exclusion criteria: • The patient's unwillingness to continue cooperation • Non-attendance of the patient
Intervention groups
In this study, the intervention means using an anti-sensitive paste formulated on the subjects' sensitive teeth and measuring the tooth sensitivity level before and after the application. The control group is the same person who has used paste without active ingredients on his opposite-side teeth.
Main outcome variables
Dental sensitivity before application; immediately after the application; 24 hours; A week; One month, and three months after the work, as well as the closure of dentin tubules under the microscope 24 hours after the work.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220829055822N1
Registration date: 2022-09-03, 1401/06/12
Registration timing: registered_while_recruiting

Last update: 2022-09-03, 1401/06/12
Update count: 0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Arsalan Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 5332
Email address
shahria951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effects of a new paste containing 8% L-Arginine and CaCO3 plus KNO3 on dentinal tubules occlusion and dental sensitivity: a randomized, triangular blinded clinical trial study
Public title
Evaluation of an anti sensitivity paste on teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients who need anti-sensitive treatment of teeth without caries • Patients in good general and oral health conditions • Not having a history of illness or long-term drug use • People who do not use orthodontic appliances
Exclusion criteria:
• The patient's unwillingness to continue cooperation • Non-attendance of the patient during visit sessions
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 16
More than 1 sample in each individual
Number of samples in each individual: 2
In the form of split-mouth, each person is both control and intervention
Randomization (investigator's opinion)
Randomized
Randomization description
The method of applying the anti-sensitive paste in this study will be split-mouth, and the choice of the treated half of the jaw as control or intervention will be random, in such a way that each patient randomly chooses the type of treatment for his/her half of the jaw. Each patient receives a sealed envelope of 8 envelopes related to his/her gender group and determines his/her control and intervention half of the jaw.
Blinding (investigator's opinion)
Triple blinded
Blinding description
One person does the application of anti-sensitive paste, and the evaluation of sensitivity is done by another person who is unaware of the type of treatment for each half of the jaw. Also, the patient does not know the contents of the received envelope. Therefore, the patient, evaluator, and statistician are blind to the type of treatment.
Placebo
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 - Mashhad University of Medical Sciences
Street address
No.2 , 16th Hakim St. Koohsangi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175966333
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.002

Health conditions studied

1

Description of health condition studied
tooth sensitivity, dental sensitivity
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures

Primary outcomes

1

Description
Dental sensitivity
Timepoint
before work; immediately after the application; 24 hours; A week; One month and three months after application
Method of measurement
For sensitivity to cold, an air-water syringe was used for 3 seconds at a distance of 1 cm from the tooth while isolating the side teeth. For palpation, the movement of the scaler probe was used in the CEJ region of the desired tooth. Finally, the VAS criterion was used to record the results.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, the synthesized paste containing the active ingredient l-arginine/calcium carbonate 8% and potassium nitrate 3% was used. 2 times on 2 consecutive days, the paste was applied in the clinic for half an hour. It was refreshed one time during the process every day. A micro brush was used for the application process while isolating the side teeth. Due to the need for saliva and its enzymes, excessive drying of the oral environment was prevented.
Category
Treatment - Drugs

2

Description
Control group: In this group, the synthesized paste without the active ingredient l-arginine/calcium carbonate 8% and potassium nitrate 3% was used. 2 times on 2 consecutive days, the paste was applied in the clinic for half an hour. It was refreshed one time during the process every day. A micro brush was used for the application process while isolating the side teeth. Due to the need for saliva and its enzymes, excessive drying of the oral environment was prevented.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry
Full name of responsible person
Arsalan Shahri
Street address
VakilAbad Blvd. Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9501
Email
web@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
معاون تحقیقات و فناوری دانشگاه علوم پزشکی مشهد
Street address
Daneshgah St. Central building of University
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
p.relations@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Arsalan Shahri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.2 ,16th HakimNezami St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175966333
Phone
+98 51 3844 5332
Fax
Email
shahria951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arsalan Shahri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.2 ,16th HakimNezami St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175966333
Phone
+98 51 3844 5332
Fax
Email
shahria951@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arsalan Shahri
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.2 ,16th HakimNezami St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9175966333
Phone
+98 51 3844 5332
Fax
Email
shahria951@mums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants: Basic information including name and age and information about the main outcome will be published.
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
Due to the non-confidentiality of the information, its use is free for everyone.
Under which criteria data/document could be used
Due to the non-confidentiality of the information, its use is free for everyone.
From where data/document is obtainable
Arsalan Shahri
What processes are involved for a request to access data/document
It will be sent to the applicant within 4 working days.
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