The elevated levels of metals in saliva are thought to occur by corrosion of the chemical elements in the alloys. The aim of this study was to compare the effect of fluoride-containing mouthwash and amorphous calcium phosphate phosphopeptide casein paste on the release of ions from orthodontic fixed devices in saliva of patients undergoing orthodontic treatment and PH of saliva.
Design
A randomized, double blinded clinical trial with a parallel group design of 36 patients will be enrolled between september and december 2019.
Settings and conduct
Saliva samples from all patients are taken at three different time points: before orthodontic treatment, 1 month after appliance placement, 2 months after appliance placement. salivary samples was analyzed by atomic absorption spectrophotometer. This measurements will be performed at Kerman Universitu of Medical Sciences stem cell research center.
Participants/Inclusion and exclusion criteria
This study will be conducted on 36 people who want fix orthodontic treatment and volunteer to participate in this study. These people have no history of systemic disease, no caries or active periodontal disease and are in permanent dental phase. They do not have any metal crowns, bridges or any nickel and chromium restorations in their mouth.
Intervention groups
Patients will be divided into 3 groups of 12 and all will receive health education. There will be no special intervention for control group but people in the secound group are asked to use ACP-CPP paste on there teeth twice a day after brushing and people in the third group are asked to spoon 15 ml of flouride mouthwash into their mouths for 30 seconds.
Main outcome variables
The concentration of nickel and chromium in the saliva is measured in ng/ml(PPB equivalent). The correlation between the salivary PH of patients and the concentration of ions in different groups is compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190827044632N1
Registration date:2019-10-05, 1398/07/13
Registration timing:registered_while_recruiting
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Behnoush Hormozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4482 3559
Email address
b.hormozi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flouride mouthwash and tooth-mousse paste usage on ion release and PH of soliva in patients undergoing fixed orthodontic treatment
Public title
Effect of flouride mouthwash and tooth-mousse paste on fixed orthodontic appliances
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No history of systemic disease
Lack of dental Caries
Absence of active periodontal disease
Patients in Permanent dental stage
No metal crowns, bridge or any nickel and chromium restorations in the patient's mouth
The patient does not have previous orthodontic treatment
Exclusion criteria:
Patient with cleft lip or palate or any type of oral syndrome
Evolutionary enamel lesions
Multiple dental restorations
History of allergy to milk proteins
Use of antibiotics during the study
Oral breathing
Smokers
Age
From 12 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient is assigned a number based on a random number table obtained by using a computer software (NCSS, Kaysville, UT, USA). Details of different groups are stored on cards and in sealed envelopes that are similar in appearance and have their own group contents. These envelops are numbered by an independent individual and assigned to patients based on the number of them.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient receives a packet containing the health contents of their group. Once the study volunteer has been evaluated by the lead researcher and his/her compliance with the inclusion criteria has been confirmed, the envelope dedicated to the patient will be opened by a senior resident in the field of orthodontics and the study process will begin.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee For Ethics In Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafshan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.KMU.REC.1398.243
Health conditions studied
1
Description of health condition studied
Ion release and PH of soliva during use of different remineralizing agents in patients undergoing fixed orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of release of nickel ion
Timepoint
Before orthodontic treatment, 1 month and 2 month after orthodontic treatment
Method of measurement
Atomic absorption spectrophotometer
Secondary outcomes
1
Description
The rate of release of chromium ion
Timepoint
Before orthodontic treatment, 1 month and 2 month after orthodontic treatment
Method of measurement
Atomic absorption spectrophotometer
Intervention groups
1
Description
Control group: All patients are instructed to brush their teeth twice a day for 3 minutes using 1450 ppm fluoride toothpaste. They are asked not to use any oral hygiene products or instruments, including Oral irrigators or antimicrobial mouthwashes, during the study.
Category
Lifestyle
2
Description
Intervention group: Following health training similar to group 1, Patients were asked to place 5 mm of ACP-CPP cream (GC Tooth Mousse, Asia Pty. Ltd, Japan) twice a day after brushing on their tooth surfaces and they were advised to keep the paste on the surface of their teeth for at least 3 minutes before washing their mouths. Patients should not take any food or drink for 30 minutes after using CPP-ACP paste, and any other fluoride supplement is not permitted.
Category
Prevention
3
Description
Intervention group: Patients are instructed to rinse 15 ml fluoride in their mouths for 30 seconds twice a day after brushing, and then refrain from eating, drinking and washing for 30 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Kerman University of Medical Sience
Full name of responsible person
Behnoush Hormozi
Street address
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
b.hormozi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
molook Torabi
Street address
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9025
Email
m_torabi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Behnoush Hormozi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
Behnoosh.hormozy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Samaneh Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
00983432119021-30
Email
samaneh_sa82@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Behnoosh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Kerman University of medical Sciences, Shafa Stree, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
Behnoosh.hormozy@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
only part of the data, such as the main outcome information, can be shared.
When the data will become available and for how long
6 month after the results are published
To whom data/document is available
researchers working in academic institutions
Under which criteria data/document could be used
For review in academic and scientific environments
From where data/document is obtainable
behnoosh.hormozy@gmail.com
What processes are involved for a request to access data/document