Evaluation of Effect of toothpaste containing nanohydroxyapatite particles on dental sensitivity , color change and Gingival Index during home bleaching treatment
Comparison of dental sensitivity intensity, rate of tooth discoloration and gingival index during home bleaching treatment following the use of toothpastes containing nanoparticles of apatite and common toothpaste
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 40 patients. The random allocation rule method (blocking with balls) was used to randomize.
Settings and conduct
This study was performed on 40 patients in the field of bleaching treatment and in the rehabilitation department of Zahedan Dental School. The type of toothpaste will be unclear to the participant and the student (outcome assessor) by simulating their external coverage by the tutor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:having natural front teeth with A2, B2, C2, D2 and darker colors (Vitapan Classic Shade); at least 24 teeth; no front restoration; good oral hygiene; patient satisfaction, people without decay; Gingivitis and periodontal disease; people with dental root exposure; no NCCL (Non-Caries Cervical Lesions); no orthopedic treatment; Anti-allergy compounds over the past three months; lack of pregnancy and lactation; lack of calculus; no history of bleaching treatment in the past; non-smokers; no change The colors of fluorosis and Tetracycline
Exit criteria:Lack of willingness of the participant to continue treatment ,Severe allergy due to bleaching treatment
Intervention groups
1- Case (toothpaste consumers containing nanohydroxy apatite particles) 2- Control (common toothpaste consumers)
Main outcome variables
Intensity of dental sensitivity - rate of discoloration - gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047374N1
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Faezeh Elahi Chatrodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3337 2116
Email address
nikadp.94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of toothpaste containing nanohydroxyapatite particles on dental sensitivity , color change and Gingival Index during home bleaching treatment
Public title
Evaluation of the clinical effects of nanohydroxy apatite toothpaste during home bleaching treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having natural front teeth with colors A2, B2, C2, D2 and darker (Vitapan Classic Shade)
Have at least 24 teeth
Lack of any kind of frontal restoration
Proper oral hygiene
People without caries in the front teeth
Lack of Gingivitis and Periodontal Diseases
No dental root exposure
Lack of NCCL (Non Caries Cervical Lesions)
Lack of ortho treatment
Patients without a history of dental sensitivity to cold and heat or expressing allergies with airborne powder tests
Do not use any anti-sensitivity compounds for the past three months
No pregnancy or lactation
Lack of Calculus
People without a history of bleaching treatment in the past
No smoking
People without florosis and tetracycline
Exclusion criteria:
Lack of willingness of the participant to continue treatment
Severe sensitivity due to bleaching treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation Rule Method (In this method, a block of 40 people is considered for sample size and 40 balls with numbers 1 to 40 are placed in one container and the first 20 balls are randomly removed and their sequence is recorded. And are placed in the first group and the remaining 20 items are placed in the second group, so that the balance in the number of people allocated in the groups will be obtained at the end of the study) will be placed in one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to simulate toothpaste, due to the similarity of the outer coating of the tube, the outer coating of the toothpaste is removed and the same coatings are placed and coded (by the instructor). Toothpaste will be unspecified for participants and students(Consequence Assessor).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Iran, Zahedan, Dr. Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.ZAUMS.REC.1399.032
Health conditions studied
1
Description of health condition studied
Tooth sensitivity after bleaching
ICD-10 code
Z40,Z54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
The severity of tooth sensitivity
Timepoint
Days 1, 3, 7, 10 and 14 after the start of bleaching
Method of measurement
based on the VAS (Visual Analog Scale)test
2
Description
The rate of tooth discoloration
Timepoint
Days 1, 3, 7, 10 and 14 after the start of bleaching
Method of measurement
Chromaticity (color intensity) with Easy shade device
3
Description
Gingival index
Timepoint
Days 1, 3, 7, 10 and 14 after the start of bleaching
Method of measurement
During a clinical examination with a probe and observing the condition of the gums
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Do prophylaxis with oil-free prophylactic paste, to remove foreign pigments one week before bleaching treatment, teaching how to brush and floss correctly (brush 3 times a day at the right time, noon, night and floss once a night), prepare a template Alginate, made by each vacuum-specific home remover by vacuum device, uses a tri-containing carbamide proxide bleaching gel with 16% whiteness perfect (FGM Dental-products, Joinville, Sc, brazil) for 4 hours a day for up to 14 days and uses common toothpaste ( Pharmad Total Care Toothpaste 100 mg, Dr. Akhavi Laboratory Company in Tehran, Made in Iran) during the period of use of a tar containing bleaching agents, delivery one anti-sensitivity tube UltraEz(Opalescencc, USA) and a number of codeine acetaminophen tablets (/ 10mg300) for pain relief medications
Category
Treatment - Drugs
2
Description
Intervention group: Do prophylaxis with oil-free prophylactic paste, to remove foreign pigments one week before bleaching treatment, teaching how to brush and floss correctly (brush 3 times a day at the right time, noon, night and floss once a night), prepare a template Alginate, home-made tri-person trials by vacuum machine, use of tri-containing carbamide proxide bleaching gel 16% whiteness perfect (FGM Dental-products, Joinville, Sc, brazil) for 4 hours a day for up to 14 days and use toothpaste containing 15% of Pharmed Normative Apatite Nanoparticles (Pharmad N-HAP Sensitive Toothpaste 100 mg, Dr. Akhavi Laboratory Company in Tehran, Made in Iran) during Use Bleaching of the more ingredients, deliver a َanti-sensitivity tube UltraEz (Opalescencc, USA) and a number acetaminophen codeine (/ 10mg300) in order to relieve the unbearable pain medications
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Restorative , Zahedan School of Dentistry
Full name of responsible person
Dr. Somayeh Hosseini Tabatabai
Street address
Iran, Zahedan, Azadegan St., School of Dentistry, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 4004
Email
somayehtabatabaei@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Iran, Zahedan, Dr. Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5796
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Faeze Elahi Chatrudi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Zahedan, East Azadegan St., School of Dentistry
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 4004
Email
Nikadp.94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Somayeh Hosseini Tabatabai
Position
Assistant Professor, Department of Restorative Dentistry, School of Dentistry, Zahedan University of
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iran, Zahedan, Azadegan St., School of Dentistry, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817966993
Phone
+98 54 3341 4004
Email
somayehtabatabaei@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Faezeh Elahi Chatrodi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Zahedan, East Azadegan St., School of Dentistry
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817966993
Phone
+98 54 3337 2116
Fax
Email
Nikadp.94@gmail.com
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