1. Home
  2. Approved trials
  3. » فارسی

Effect of nano hydroxyapatite toothpastes and mouth rinse on eroded enamel and dentin - an in situ study

Protocol summary

Study aim
This study aims to investigate the effect of different toothpaste and mouthwashes on dentin erosion/abrasion (in situ study design) using surface microhardness, roughness and surface wear methods.
Design
Randomized clinical trial, with a control group, cross-over, double-blind, phase 3 on 21 patients
Settings and conduct
The participants will be selected in Shiraz Dental School. A full explanation about the purpose of the study and how to implement it and its steps will be provided to the participants. The study is double-blind. The patient, the researcher and the interpreter do not know about the grouping.
Participants/Inclusion and exclusion criteria
The inclusion criteria:being at least 18 years old, having good general and oral health, not being allergic to certain substances including oral hygiene products or dental materials, non-stimulated and stimulated saliva flow more than 0.25 ml/min and more than 0.25 ml/min, respectively. The absence of active caries lesions or non-carious lesions such as cervical lesions and periodontal disease, the absence of dental prostheses and orthodontic appliances, the absence of erosive lesions in the teeth, and the possibility of visiting at recalls.
Intervention groups
Group 1 (negative control): distilled water is used in this group (appliance without using toothpaste). Group 2 (positive control): using Elmex ® erosion protection toothpaste followed by Elmex ® erosion protection mouthwash Group 3: using Vitis® anticaries with nanorepair toothpaste . Then use Vitis® anticaries mouthwash
Main outcome variables
Surface microhardness, Surface roughness, Surface wear

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110823007402N9
Registration date: 2023-01-23, 1401/11/03
Registration timing: prospective

Last update: 2023-01-23, 1401/11/03
Update count: 0
Registration date
2023-01-23, 1401/11/03
Registrant information
Name
Mahtab Memarpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3192
Email address
memarpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-05, 1402/01/16
Expected recruitment end date
2023-05-06, 1402/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nano hydroxyapatite toothpastes and mouth rinse on eroded enamel and dentin - an in situ study
Public title
Effect of nano hydroxyapatite toothpaste and mouthwash on enamel and dentin erosion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1) Being at least 18 years old 2) Having good general and oral health 3) Not being allergic to certain substances including oral hygiene products or dental materials 4) Non-stimulated and stimulated saliva flow more than 0.25 ml/min and more than 0.25 ml/min, respectively. 5) The absence of active caries lesions or non-carious lesions such as cervical lesions and periodontal disease 6) The absence of dental prostheses and orthodontic appliances 7) The absence of erosive lesions in the teeth 8) The possibility of visiting at recalls.
Exclusion criteria:
1) Pregnancy or intention to become pregnant during the study 2) Breastfeeding 3) Simultaneous participation in another study 4) Professional use of fluoride in the last two months 5) Inability to implement the study protocols 6) Receiving medical treatment 7) Using drugs that Interference with the flow of saliva 8) Having digestive problems 9) Smoking
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 21
More than 1 sample in each individual
Number of samples in each individual: 8
-
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block. The size of all the blocks will be equal. Sequence generation software is also used for randomization. Sequentially numbered, sealed, opaque envelopes are used for random concealment. In this method, each random sequence created is recorded on a card and the cards inside and the letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The size of all the blocks will be equal. Sequence generation software is also used for randomization. Sequentially numbered, sealed, opaque envelopes are used for random concealment. In this method, each random sequence created is recorded on a card and the cards inside and the letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
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
Administration Building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2022-10-19, 1401/07/27
Ethics committee reference number
IR.SUMS.DENTAL.REC.1401.108

Health conditions studied

1

Description of health condition studied
enamel and dentin erosion
ICD-10 code
K03.2
ICD-10 code description
Erosion of teeth

Primary outcomes

1

Description
Surface microhardness, roughness and surface wear
Timepoint
5 days after the erosive/abrasive challenge
Method of measurement
Measuring surface wear with contact profilometry, surface hardness using Vickers test, surface roughness with atomic force microscope

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group (positive control): using Elmex ® erosion protection toothpaste (GABA International AG, Therwil, Switzerland) containing 3500 ppm of tin ions in the form of tin chloride and 1400 ppm of fluoride ions with pH = 4.5. followed by Elmex® erosion protection mouthwash containing 800 ppm of tin ions in the form of tin chloride and 500 ppm of fluoride ions with pH = 4.5. The second intervention group: using Vitis® anticaries toothpaste with nanorepair (VITIS Oral HealthC/O Dent- O-Care, London, UK) containing 1450 ppm fluoride ions in sodium monofluorophosphate, 0.45% nanohydroxyapatite and 10% xylitol. Then using Vitis® anticaries mouthwash containing 1450 ppm fluoride ions in sodium monofluorophosphate, 0.45% nanohydroxyapatite and 10% xylitol.
Category
Prevention

2

Description
Control group: In this group, distilled water is used (appliance without using toothpaste).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz dental school
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Dental school, Gasrdasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
15878- 71956
Phone
+98 71 3626 3193
Email
dental@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Dental school, Gasrdasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
15878- 71956
Phone
+98 71 3636 3193
Email
memarpour@sums.ac.ir
Grant name
Vice Chancellery of Research of Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mahtab Memarpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Ghomabad, Ghasrodasht
City
Shiraz
Province
Fars
Postal code
15878- 71956
Phone
+98 71 1626 3192
Fax
+98 71 1627 0325
Email
memarpour@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Ghomabad, Ghasrodasht
City
Shiraz
Province
Fars
Postal code
15878- 71956
Phone
+98 71 1626 3192
Fax
+98 71 1627 0325
Email
memarpour@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Gasrdasht Street, Shiraz
City
Shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3626 3192
Email
memarpour@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information exists
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...