The effect of Nano hydroxyapatite_containing tooth paste on enamel demineralization during the first six months of fixed orthodontic treatment- A triple-blind randomized clinical trial
The objective of the present study is to discover the preventive effects of Nanohydroxyapatite toothpaste on enamel demineralization.
Design
This will be a triple-blind randomized controlled trial with a 1:1 allocation ratio and 2 parallel groups, examining the superiority of Nano hydroxyapatite containing toothpaste for preventing enamel demineralization during fixed orthodontic treatment compared with fluoride containing toothpaste.
Settings and conduct
The trial will be triple-blinded. Both the participants and clinician will be masked to group allocation and they will not be aware of the type of toothpaste. The person who uses DIAGNOdent to measure the enamel demineralization is also unaware of how individuals are assigned to the groups. Furthermore, the individual analyzing the data will be unaware of the study protocol.
Participants/Inclusion and exclusion criteria
The inclusion criteria: (1) need for comprehensive orthodontic treatment by fixed appliances at least in the upper arch; (2) permanent dentition; (3) no plaque accumulation or gingival inflammation before bracket bonding; (4) good general health. The exclusion criteria: patients with smoking habit, tooth anomalies and active dental caries.
Intervention groups
Before treatment, patients in the experimental and control groups will be trained to maintain oral hygiene (according to a form prepared for this purpose) and brush 3 times a day with Nano hydroxyapatite and white fluoride (Colgate, Colgate-Palmolive Co. New York, New York, United states) toothpaste respectively. All patients will be instructed to brush their teeth by soft toothbrush and interdental brush. The patient will be reviewed every 4 to 6 weeks.
Main outcome variables
The goal is to evaluate the preventive effect of Nano hydroxyapatite containing tooth paste on enamel demineralization during the first six months of fixed orthodontic treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045518N2
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Ahmadreza Sardarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3193
Email address
sadra.sardarian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-06, 1400/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nano hydroxyapatite_containing tooth paste on enamel demineralization during the first six months of fixed orthodontic treatment- A triple-blind randomized clinical trial
Public title
Effect of Nano hydroxyapatite_containing tooth paste on the health of the enamel during orthodontic treatment.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Need for comprehensive orthodontic treatment by fixed appliances at least in the upper arch
Permanent dentition
No plaque accumulation or gingival inflammation before bracket bonding
Good general health
Exclusion criteria:
Patients with smoking habit
Patients with tooth anomalies
Patients with active dental caries
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be carried out using a computer-generated random number sequence to produce random samples. Each consecutive patient labeled by random number go through block randomization with a block length 18.
The patients will be equally divided into two groups, namely, the TP1 and TP2 group. The distribution of the group to be first assigned will be recorded on sequentially numbered cards and placed in opaque and sealed envelopes. Each participant randomly picks one envelope corresponding to either the TP1 or TP2 group. Once the participant is eligible for the procedure and all initial evaluations are completed, the allocation assignment will be revealed by opening the envelope immediately after implementation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The trial will be triple-blinded. Both the participants and clinician will be masked to group allocation and they will not be aware of the type of toothpaste. The toothpastes given to the patients will be subjected to surface treatment with an abrasive cloth to remove all information regarding its contents. That way, the patients and the clinician responsible for the treatment will be blinded to the treatment that they receive. The person who uses DIAGNOdent to measure the enamel demineralization is also unaware of how individuals are assigned to the groups. Furthermore, the individual analyzing the data will be unaware of the study protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Orthodontics Research Center, Department of Orthodontics, Shiraz University of Medical Science, Shiraz, Iran
The amount of enamel demineralization is measured by the number indicated by the DIAGNOdent device.
Timepoint
The enamel demineralization will be recorded 3 times during the first 6 months of fixed orthodontic treatment. At the start of the study and 3, 6 months during the treatment.
Method of measurement
Evaluating by DIAGNOdent device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The teeth will be etched at the bracket base area with 37% phosphoric acid for 15 seconds, rinsed, and dried. Transbond XT Adhesive Primer and Transbond XT Adhesive Resin will be used for bonding metal brackets .Bonding procedures will be performed according to the manufacturer’s instructions. Stainless steel brackets will be placed and firmly pressed onto the enamel surfaces and excess adhesive will be removed from the bracket base periphery. If a slight bit of excess adhesive is present after setting (especially along the gingival margin), it will be removed with burs. Patients in the experimental group brush with Nano-hydroxyapatite toothpaste 3 times a day.
Category
Treatment - Other
2
Description
Control group: The teeth will be etched at the bracket base area with 37% phosphoric acid for 15 seconds, rinsed, and dried. Transbond XT Adhesive Primer and Transbond XT Adhesive Resin will be used for bonding metal brackets .Bonding procedures will be performed according to the manufacturer’s instructions. Stainless steel brackets will be placed and firmly pressed onto the enamel surfaces and excess adhesive will be removed from the bracket base periphery. If a slight bit of excess adhesive is present after setting (especially along the gingival margin), it will be removed with burs. Patients in the control group brush with fluoride toothpaste 3 times a day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, Faculty of Dentistry, Shiraz University, Shiraz, Iran
Full name of responsible person
Ahmadreza Sardarian
Street address
Faculty of Dentistry, Qasrdasht St., Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3628 0112
Email
sardarian@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi Pharm.D , PhD
Street address
Vice Chancellor for Research and Technology, 7th floor, Shiraz University of Medical Sciences, Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ahmadreza Sardarian
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Qasrdasht, Shiraz,
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 917 718 8859
Email
sardarian@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmadreza Sardarian
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Qasrdasht, Shiraz,
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 917 718 8859
Email
sardarian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmadreza Sardarian
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Qasrdasht, Shiraz
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 917 718 8859
Email
sardarian@sums.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
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
All patient data can be tracked through the journal site.
When the data will become available and for how long
The data will be provided to the journal and the exact time of availability of the information will be announced by the journal.
To whom data/document is available
Eligibility for access to information is determined by the relevant journal rules.
Under which criteria data/document could be used
Eligibility for access to information is determined by the relevant journal rules.
From where data/document is obtainable
All patient data can be tracked through the journal site. Therefore, by searching for articles on reputable sites, it will be possible to follow and access information.
What processes are involved for a request to access data/document
All patient data can be tracked through the journal site. Therefore, by searching for articles on reputable sites, it will be possible to follow and access information.