The aim of this study was to compare the effect of alpha and Danes toothpaste on salivary pH change.
Design
Double-blind, randomized, phase 4 clinical trial on 40 patients, even and odd numbers were used for randomization
Settings and conduct
Wait 5 minutes for the samples and then pour 5 cc of the collected spitting saliva into the laboratory tube. In the first intervention, 2 cc of toothpaste is given to the samples.
After the allotted time, people are asked to rinse their mouths with water.
Individuals are asked to collect their saliva for five minutes and then drain it into a laboratory tube.
people are given 72 hours to have a normal diet. At this stage, observing all the aspects and instructions provided, for the second time, we measure the pH of the saliva of the mouths of people in groups one and two before brushing.
Then, by applying considerations, the second intervention is performed
Participants/Inclusion and exclusion criteria
Inclusion criteria:
are among the students of Sanandaj Dental School. have completed the consent form. Be in the age group of 35-38 years. should not be affected by systemic diseases that affect saliva. have not recently undergone radiotherapy. Do not use antihypertensive drugs and antibiotics continuously.
Exclusion criteria: are allergic to toothpaste compounds. If you do not participate in the second stage of intervention.
Intervention groups
People in group one use alpha toothpaste in the first intervention and Sensodyne toothpaste in the second intervention. People in group 2 use Sensodyne toothpaste in the first intervention and alpha toothpaste in the second intervention. First, to remove food debris, they rinse their mouths with water several times, then both groups are given 2 cc of toothpaste in each intervention to scrub for 3 minutes. After 72 hours, the second intervention is performed.
Main outcome variables
Salivary pH change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201213049704N1
Registration date:2021-04-11, 1400/01/22
Registration timing:prospective
Last update:2021-04-11, 1400/01/22
Update count:0
Registration date
2021-04-11, 1400/01/22
Registrant information
Name
Ramazan Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3559 1128
Email address
e.ramazan1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-04, 1400/02/14
Expected recruitment end date
2021-05-09, 1400/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on effect of Alpha danan and sensodyne toothpastes on pH salivary chang.
Public title
A comparative study on effect of Alpha danan and sensodyne toothpastes on pH salivary chang.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Samples are among the students of Sanandaj Dental School.
Samples complete the consent form.
Be in the age group of 35-18 years.
. The specimens do not have systemic diseases that affect saliva, such as diabetes, asthma, kidney and liver failure, epilepsy, blood and glandular disorders.
. Samples do not have removable orthodontic appliances and prostheses.
Samples have not recently undergone radiotherapy.
Samples are not smokers.
Samples Do not use antihypertensive drugs and antibiotics regularly.
Exclusion criteria:
1. Samples are allergic to toothpaste compounds.
2. If you do not participate in the second stage of intervention.
Age
From 18 years old to 35 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant will participate in the first and second phases of the intervention and will use a specific type of toothpaste in each intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
The names of the people who are eligible to enter the research are written on separate cards and we put them all in a pot, then the people who are pulled out one by one, form the research samples that Simple random forms are divided into groups one and two, for this purpose, according to the number of sample people, we put cards in the pot on which we write the number one and the other half number two, and the people based on their card number in There are one or two groups (depending on the type of study (cross-clinical trial), each person is measured against himself / herself, so there is no need to match the groups in terms of age and gender).
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding participants: To eliminate bias, we use double-blind, for this purpose, two types of toothpaste are poured into similar white tubes so that it is not possible to identify the type of toothpaste by the samples and the amount of error and Minimize orientation.
Outcome Evaluation Blindness: The pH measurement with a pH meter is performed by a research student who has acquired the necessary skills to do so and is unaware of the type of toothpaste used by the samples.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kurdestan University of Medical Sciences
Street address
Kurdistan Besat Medical Sciences Dormitory, Above Jam Jam Crossroads, Adab Street
City
Sanandaj
Province
Kurdistan
Postal code
6617939438
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.MUK.REC.1398.280
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
Saliva pH
Timepoint
In the first intervention: before brushing with toothpaste and after brushing with toothpaste. 72 hours later, perform the second intervention: before brushing with toothpaste and after brushing with toothpaste
Method of measurement
PH meter model pH meter BASIC 20+
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Group I (half of the study volume, which uses alpha toothpaste in the first intervention and toothpaste under the brand name Sensodyne in the second intervention (72 hours later)). Group two (half of the study volume that used toothpaste under the brand name Sensodyne in the first intervention and alpha toothpaste in the second intervention (72 hours later).)
Category
Other
2
Description
Control group: According to the type of study (crossover clinical trial), each person is measured against himself. In other words, the intervention groups at each stage are their control group for the next intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan Dental School of Medical Sciences
Full name of responsible person
Ramazan.Ebrahimi
Street address
Kurdistan Medical Sciences Dormitory، Adab Street, above Jam Jam Crossroads
City
Sanandaj
Province
Kurdistan
Postal code
6617939438
Phone
+98 87 3559 1128
Email
e.ramazan1375@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Adab Street, above Jam Jam Crossroads
City
Sanandaj
Province
Kurdistan
Postal code
6617939438
Phone
+98 87 3559 1128
Email
e.ramazan1375@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Mohammad Rastegar Khosravi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617939438
Phone
+98 87 3559 1128
Email
bababarbod@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mohammad Rastegar Khosravi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanadaj
Province
Kurdistan
Postal code
6617939438
Phone
+98 87 3559 1128
Email
bababarbod@gamil.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ramazan Ebrahimi
Position
dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617939438
Phone
+98 87 3559 1128
Email
e.ramazan1375@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available