Comparison of influence of whitening and regular dentifrices on color stability of orthodontic clear ligatures in oral environment
Design
A randomized, double-blind, randomized controlled clinical trial was performed on 66 patients using the randomization tables available at www.stattrek.com.
Settings and conduct
Patients who are undergoing fixed orthodontic treatment at Ahwaz Dental School are selected at the end of the teeth alignment phase. After obtaining informed consent, Orthogonizers brand ligatures are used on the lower anterior teeth of all patients. Patients are randomly divided into three groups of 22 patients. Patients are asked to brush their teeth twice a day for 5 minutes each time using the toothpaste. Canon cameras are used to determine the primary color.All photos are taken in the same environment and light. It is then placed in the mouth for 4 weeks and the patient brushes the ligatures using the appropriate toothpaste and is removed after this period. Then the samples are photographed again and all the photos ( Both primary and post-oral photographs are examined to determine the color of the ligatures using Photoshop 2019 software to evaluate the L, a, and b parameters.
Participants/Inclusion and exclusion criteria
The patient is willing to participate in the study, Have a good level of oral health, 4 lower anterior teeth are aligned and without diastema, Do not use any mouthwash, medication, tobacco or special diet, Absence of systemic diseases ؛ Patient non-cooperation
Intervention groups
The first group uses Arm & Hammer Advance White Extreme toothpaste, the second group uses Crest Complete Extra Whitening toothpaste and the third group uses regular Crest Cavity Protection toothpaste.
Main outcome variables
The effectiveness of Arm & Hammer Advance White, Crest Complete Extra Whitening and Crest Cavity Protection toothpaste on color stability of the elastic ligature
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220315054292N1
Registration date:2022-03-28, 1401/01/08
Registration timing:prospective
Last update:2022-03-28, 1401/01/08
Update count:0
Registration date
2022-03-28, 1401/01/08
Registrant information
Name
Majid Aryannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3376 5825
Email address
aryannejad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of whitening and regular dentifrices on color stability of orthodontic clear ligatures in oral environment
Public title
Influence of whitening and regular dentifrices on color stability of orthodontic clear ligatures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is willing to participate in the study
Have a good level of oral health
4 lower anterior teeth are aligned and without diastema
Do not use any mouthwash, medication, tobacco or special diet
Absence of systemic diseases
Exclusion criteria:
Patient non-cooperation
Age
From 15 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Using random tables available at www.stattrek.com, they are selected by simple individual randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using tubes that do not have the specifications of the relevant toothpaste on them and the tubes are named by the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Ahvaz Jundishapur University of Medical Sciences and Health Services, Vice Chancellor for Research and Technology, University City, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.AJUMS.REC.1400.698
Health conditions studied
1
Description of health condition studied
Influence of whitening and regular dentifrices on color stability of orthodontic clear ligatures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of discoloration of clear orthodontic ligatures
Timepoint
Record the primary color of the ligatures , 28
Method of measurement
The samples are photographed and all photos (both initial and post-oral photos) to determine the color of the ligatures using Photoshop software version 4. 0. 20 (Adobe Photo Shop cc 2019) for evaluation Parameters L, a, b are checked.
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: Arm & Hammer Advance White Extreme Whitening Toothpaste , Second Intervention group: Crest Complete Extra Whitening toothpaste
Category
Diagnosis
2
Description
Control group: Crest Toothpaste Cavity Protection Regular