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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200906048639N1
Enrollment
32
Registered
2021-02-28
Start date
2021-04-04
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Discoloration.

Interventions

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).

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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 ?E = v (?(a2-a1)? ^ 2 + ?(b2-b1)? ^ 2 + ?(L2-L1)? ^ 2) for Each Tooth.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahla Rezaei

Mashhad University of Medical Sciences

rezaeiM981@mums.ac.ir+98 51 3865 8162

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026