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IRCT20200906048639N1 IRCT 2021-02-28 Mashhad University of Medical Sciences Evaluation of Whitening Effectiveness and Tooth Sensitivity of the Formulated In-Office Bleaching Gel Containing Hydrogen Peroxide and a Remineralizing Agent 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 2021-04-04 anticipated 32 Complete https://irct.ir/trial/50792 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Tooth Discoloration. Intervention 1: 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). Intervention 2: 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). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mahla Rezaei
5th Floor, No. 69, Daneshjoo 17 St., Daneshjoo Blvd., Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) 9188945981 +98 51 3865 8162 rezaeiM981@mums.ac.ir Mashhad University of Medical Sciences scientific Hamideh Sadat Mohammadipour
School of Dentistry, in front of Mellat Park, First of Vakilabad Blvd.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 mohammadipourh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 18 years 40 years Both 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 Treatment - Other Placebo 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). 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). 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. 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. 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. 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. Mashhad University of Medical Sciences Approved 2020-12-22 Ethics Committee of Mashhad Dental School School of Dentistry, in front of Mellat Park, First of Vakilabad Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)