Comparison of the effect of toothpaste containing CPP_ACPF and toothpaste containing propolis in the treatment of dentin hypersensitivity
Design
Randomized clinical trial without control group, parallel groups trial with blinded statistical analyzer; phase 2 on 20 patients.
Settings and conduct
This study will be done on patients with dentin hypersensitivity referring department of periodontics of Isfahan University. Two propolis Herbex and GC MI PASTE PLUS pastes are tested. Statistical analyzer is blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to the general and specialized periodontics department of Isfahan Dental School; Teeth do not need restorative treatment; People over 18 years old.
Non-inclusion criteria: erosion, abrasion, attrition, crack , pulp inflammation, chronic disease and periodontal disease; active caries, restored teeth, coronary fractures; Pregnancy and lactation; smoking; use anti-sensitive toothpaste during the last 6 weeks; sensitivity to milk protein and Benzoate
Intervention groups
Intervention group 1:CPP_ACPF Use of GC MI PASTE PLUS once a day for two months. Intervention group 2: Propolis Use of PROPOLIS HERBEX toothpaste with a soft toothbrush twice a day for two months.
Main outcome variables
Dentin sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120901010703N4
Registration date:2020-11-17, 1399/08/27
Registration timing:prospective
Last update:2020-11-17, 1399/08/27
Update count:0
Registration date
2020-11-17, 1399/08/27
Registrant information
Name
Narges Naghsh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 5564
Email address
n_naghsh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effects of CPP-ACPF paste and propolis tooth paste on treatment of dentinal hypersensitivity.
Public title
Comparison of the effect of CPP-ACPF and propolis in the treatment of dentin sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the general and specialized periodontics department of Isfahan Dental School have at least 2 teeth with complaints of cervical dentin sensitivity and sensitivity to cold stimuli that are not adjacent to each other
Patients should be available for three months during the study period and sign the informed consent form
Teeth do not need restorative treatment
People over 18 years old
Exclusion criteria:
Erosion, abrasion, attrition, crack and pulpitis, chronic disease and periodontal disease
Existence of active caries, restored teeth, coronary fractures
Candidate teeth receiving veneers, teeth with ortho braces
People who have received antihistamines, antidepressants, and sedatives in the month before or during the study.
Pregnant and lactating people
smoking
Patients who have used anti-sensitive toothpaste for the past 6 weeks.
Milk protein sensitivity
Sensitivity to benzoate
Improper diet (use of sour and acidic foods)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
2 teeth
Randomization (investigator's opinion)
Randomized
Randomization description
According to the number of available pastes, there are papers with the paste name written on them and placed in a box. Each sample person picks a paper from the box and receives the desired paste.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer does not know the type of paste used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology; Building No. 4; Isfahan University of Medical Sciences and Health Services; Hezar Jerib St.,
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2020-09-23, 1399/07/02
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.421
Health conditions studied
1
Description of health condition studied
Dentin hypersensitivity
ICD-10 code
K03.89
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
Amount of patient's pain (dentin hypersensitivity)
Timepoint
Before treatment, 15 minutes after treatment in the first session, one week after the first session, two weeks after the first session, one month after the first session, two months after the first session
Method of measurement
Use of cold spray, use of air syringe of unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Herbex toothpaste, contains propolis. Brush teeth twice a day for two months. It is produced by Dr. Jahangir Knowledge-Based Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Intervention group 2: GC MI Paste Plus. Contains CPP_ACPF. Once a day for two months, after brushing, at least one pea size for each jaw is placed on the surface of the teeth with the help of a clean, dry finger. It is produced by GC AMERICA INC
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Elham Amini
Street address
Department of Periodontics; Dentistry School; Isfahan University of Medical Sciences and Health Services; Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3792 5569
Email
elhamamini9475@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Building No. 4; Vice Chancellor for Research and Technology; Isfahan University of Medical Sciences and Health Services; Hezar Jrib street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.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
Narges Naghsh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2870
Fax
+98 31 1668 7080
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Naghsh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
narges naghsh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
n_naghsh@dnt.mui.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