Evaluation of Whitening Effectiveness and Tooth Sensitivity of the Formulated In-Office Bleaching Gel Containing 40% Hydrogen Peroxide and a Remineralizing Agent: A Triple Blinded Randomized Clinical Trial
Determining the Effect of Bleaching Gel Containing a Remineralizing Agent on Whitening and Tooth Sensitivity After Bleaching
Design
A Triple Blinded Randomized Controlled Clinical trial with a parallel group design of 32 patients. Sealed Envelopes Are Used for Randomization.
Settings and conduct
This Study Will be Performed in a "Split Mouth" Design. In the Quadrant of Control a Bleaching Gel Containing 40% Hydrogen Peroxide Is Used, and In the Quadrant of Test a Bleaching Gel with a Remineralizing Agent Is Used. Before Starting, Immediately After Finishing Work, 24 Hours, One Week, One Month, Three Months and Six Months Later, the Tooth Sensitivity to Cold, Touch and Spontaneous Sensitivity are Assessed by "Visual Analogue Scale" and the color of the teeth is Recorded by the Spectrophotometer. The Location of the Study Is Mashhad Dental School. The Study Is Triple Blinded: In this way, the Participants, the Analyzer, and the Statistician Are Unaware of the Allocation of the Test and Control Groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:18 to 40 Years Old; Indication of Bleaching Treatment; Absence of Caries or Restoration on the Labial Surface of the Teeth; Good Oral Hygiene; Absence of Tooth Sensitivity
No Inclusion Criteria: History of Disease or Long-Term Medication; Using Orthodontic Appliances; Periodontal Disease; Lactating and Pregnant Women; Conditions of Increased Dental Sensitivity such as Exposed Dentin; History of Anti-Sensitivity Treatments in the Last Six Months; History of Bleaching Treatment
Intervention groups
Intervention Group: Using Bleaching Gel Containing 40% Hydrogen Peroxide and a Remineralizing Agent
Control Group: Using Bleaching Gel Containing 40% Hydrogen Peroxide and Free of Remineralizing Agent
Main outcome variables
Tooth Sensitivity to Cold, Touch and Spontaneous sensitivity
Amount of Tooth Whitening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200906048639N1
Registration date:2021-02-28, 1399/12/10
Registration timing:prospective
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Mahla Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3865 8162
Email address
rezaeim981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Whitening Effectiveness and Tooth Sensitivity of the Formulated In-Office Bleaching Gel Containing 40% Hydrogen Peroxide and a Remineralizing Agent: A Triple Blinded Randomized Clinical Trial
Public title
Evaluation of Whitening Effectiveness and Tooth Sensitivity of the Formulated In-Office Bleaching Gel Containing Hydrogen Peroxide and a Remineralizing Agent
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients for whom Bleaching Treatment Is Indicated, So that the Teeth that Need Bleaching Should be Free of Caries or Previous Restoration on the Labial Surface
Patients in Optimal General and Oral health Conditions
Patients without Complaints of Dental Sensitivity to Touch and to Thermal Stimuli
Patients Aged 18 to 40 Years
Exclusion criteria:
Patients with a Long History of Illness or Medication
Patients Using Orthodontic Appliances
Patients with Periodontal Disease or Poor Oral Hygiene
Children and Women who Are Breastfeeding or Pregnant
Patients with Conditions of Hypersensitivity such as Dentin Exposure and Non-Carious Cervical Lesions
People who Have a History of Anti-Sensitivity Treatments in the Last Six Months
People who Have Previously Had Bleaching Treatment
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
This Study Will be Performed in a "Split Mouth" Design. One Quadrant of the Maxilla Arch Is Considered as the Test Group and the Opposite Quadrant Considered as the Control Group.
Randomization (investigator's opinion)
Randomized
Randomization description
In This Study, the "Simple" Randomization Method Is Used. Sealed Envelopes Are Randomly Given to Each Participant to Determine their Quadrant of Testing and Control. This Is Done by Someone Other than the Evaluator of the Study Parameters.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In This Study, the Participants, the Analyzer, and the Statistician Are Unaware of the Allocation of the Groups (Assigning the Right or Left Maxillary Quadrant to the Test or Control Group). In This Way, Inserting the Bleaching Gels into the Test and Control Syringes as well as the Application of Gels on the Teeth by One Person, the Evaluation of the Color and Sensitivity of the Teeth by Another Person and the Statistical Analysis of Data by Another Person Will be Done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad Dental School
Street address
School of Dentistry, in front of Mellat Park, First of Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.114
Health conditions studied
1
Description of health condition studied
Tooth Discoloration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tooth Sensitivity to Cold Stimulus
Timepoint
Before Starting Treatment, Immediately After Treatment, 24 Hours, One Week, One Month, Three Months and Six Months After Treatment
Method of measurement
Using the "Visual Analogue Scale" from Minimum Sensitivity (Score 0) to Unbearable Pain (Score 10): The Cold Stimulus Is Applied to the Surface of the Lateral Tooth in the Cervical Third of the Tooth by Air Force from a Distance of One Centimeter for Three Seconds.
2
Description
Tooth Sensitivity to Touch with Explorer
Timepoint
Before Starting Treatment, Immediately After Treatment, 24 Hours, One Week, One Month, Three Months and Six Months After Treatment
Method of measurement
Using the "Visual Analogue Scale" from Minimum Sensitivity (Score 0) to Unbearable Pain (Score 10): The Touch Stimulus Is Produced by the Tip of a Explorer on the Cervical of the Tooth.
3
Description
Spontaneous Sensitivity Reported by Patients
Timepoint
Before Starting Treatment, Immediately After Treatment, 24 Hours, One Week, One Month, Three Months and Six Months After Treatment
Method of measurement
Using the "Visual Analogue Scale" from Minimum Sensitivity (Score 0) to Unbearable Pain (Score 10): Spontaneous Sensitivity Will be Recorded by Asking Patients.
4
Description
Bleaching Gel Whitening or Discoloration of the Teeth
Timepoint
Before Starting Treatment, Immediately After Treatment, 24 Hours, One Week, One Month, Three Months and Six Months After Treatment
Method of measurement
Tooth Color is Recorded by Spectrophotometer, then the Amount of Total Discoloration Between Each Measurement Step, Is Calculated by the Formula ΔE = √ (〖(a2-a1)〗 ^ 2 + 〖(b2-b1)〗 ^ 2 + 〖(L2-L1)〗 ^ 2) for Each Tooth.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Custom Made Bleaching Gel Containing 40% Hydrogen Peroxide and a Remineralizing Agent Is Placed on the Enamel Surface for 45 Minutes (Three 15-Minutes Periods).
Category
Treatment - Other
2
Description
Control group: The Custom Made Bleaching Gel Containing 40% Hydrogen Peroxide and Free of Remineralizing Agent Is Placed on the Enamel Surface for 45 Minutes (Three 15-Minutes Periods).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Mahla Rezaei
Street address
School of Dentistry, in front of Mellat Park, First of Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
contact@email.com
Web page address
https://dentistry.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology, Ghoreshi Building, Near The Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?