Back to resultsAt-home Bleaching Using Clear Aligners
Primary Purpose
Tooth Discoloration, Tooth Sensitivity, Gingivitis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Whitening
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Discoloration focused on measuring At-home tooth bleaching, Clear aligner, Tooth sensitivity, Gingival irritation, Patient´s satisfaction
Eligibility Criteria
The inclusion criteria will be the following: Patients over 18 years of age. Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth. Absence of cavities in the teeth to be whitened. Patients with satisfactory oral hygiene, and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine rinses. Patients with recessions without sensitivity are included. Absence of sensitivity, measured based on stimulation with the air from the syringe. Patients who are at least in A2-A3 color (Vita Classic Guide) The exclusion criteria will be the following: Patients who have previously undergone whitening (less than 5 years). Patients undergoing orthodontic treatment. Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis). Patients with a history of trauma to anterior teeth. Patients who require internal whitening. Smokers. Pregnant or lactating women. Allergy to any component of whitening. Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.). Medical conditions considered by the researchers that may compromise the study or the individual safety of the patient. Patients with poor oral hygiene. Patients with previous hypersensitivity.
Sites / Locations
- Clínica Dental IturraldeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional tray
Clear aligner
Arm Description
Two simple randomizations will be performed using a software program freely available online (www.sealedenvelop.com). For the first randomization, for each participant, the group (type of tray) will be randomized and it will always be applied to the participant's right hemiarch (n=40) according to the model: conventional tray or clear aligner. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of the tray and the aligner: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.
The patients will use the clear aligner on their right hemiarch and according to the second randomization it will be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.
Outcomes
Primary Outcome Measures
Color change evaluation
The color will be assessed using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade).
Secondary Outcome Measures
Intensity and absolute risk of tooth sensitivity
They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.
Intensity and absolute risk of gingival irritation
They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.
Patient´s satisfaction
It will be measured with a questionnaire using a visual analog scale (EVA), when a conventional bleaching tray or a clear aligner is used to perform a at home bleaching treatment with 10% carbamide peroxide.
Full Information
NCT ID
NCT05835453
First Posted
April 18, 2023
Last Updated
September 12, 2023
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT05835453
Brief Title
At-home Bleaching Using Clear Aligners
Official Title
At-home Bleaching With the Use of Clear Aligners: Randomized Single-blind Equivalence Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present project is to clinically evaluate the bleaching effectiveness, tooth sensitivity, gingival irritation and patient´s satisfaction during a at-home bleaching with 10% carbamide peroxide using a conventional bleaching tray or a clear aligner.
Detailed Description
Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, conventional or clear aligner. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours for 4 weeks. The color will be assessed at baseline, after one, two, four weeks, and at 1 month after bleaching treatment using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Patient´s satisfaction will be evaluated at baseline, after one and two weeks, and at 1 month after bleaching treatment with an apropriate questionnaire using a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Tooth Sensitivity, Gingivitis, Satisfaction, Patient
Keywords
At-home tooth bleaching, Clear aligner, Tooth sensitivity, Gingival irritation, Patient´s satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a randomized, single blind (evaluators), split mouth and equivalence study.
Masking
InvestigatorOutcomes Assessor
Masking Description
It will be a single-blind study in which only the evaluator will not know the designation of the groups because he has not participated in the study's randomization and implementation process. Due to the tray test and demonstration of the bleaching procedure, the operator and the participant cannot be blinded.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional tray
Arm Type
Active Comparator
Arm Description
Two simple randomizations will be performed using a software program freely available online (www.sealedenvelop.com). For the first randomization, for each participant, the group (type of tray) will be randomized and it will always be applied to the participant's right hemiarch (n=40) according to the model: conventional tray or clear aligner. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of the tray and the aligner: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.
Arm Title
Clear aligner
Arm Type
Active Comparator
Arm Description
The patients will use the clear aligner on their right hemiarch and according to the second randomization it will be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday.
Intervention Type
Other
Intervention Name(s)
Whitening
Intervention Description
Two syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each tray, completing a total of 4 weeks of whitening procedure.
Primary Outcome Measure Information:
Title
Color change evaluation
Description
The color will be assessed using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade).
Time Frame
Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Secondary Outcome Measure Information:
Title
Intensity and absolute risk of tooth sensitivity
Description
They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.
Time Frame
Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Title
Intensity and absolute risk of gingival irritation
Description
They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide.
Time Frame
Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
Title
Patient´s satisfaction
Description
It will be measured with a questionnaire using a visual analog scale (EVA), when a conventional bleaching tray or a clear aligner is used to perform a at home bleaching treatment with 10% carbamide peroxide.
Time Frame
Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The inclusion criteria will be the following:
Patients over 18 years of age.
Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
Absence of cavities in the teeth to be whitened.
Patients with satisfactory oral hygiene, and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine rinses. Patients with recessions without sensitivity are included.
Absence of sensitivity, measured based on stimulation with the air from the syringe.
Patients who are at least in A2-A3 color (Vita Classic Guide)
The exclusion criteria will be the following:
Patients who have previously undergone whitening (less than 5 years).
Patients undergoing orthodontic treatment.
Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis).
Patients with a history of trauma to anterior teeth.
Patients who require internal whitening.
Smokers.
Pregnant or lactating women.
Allergy to any component of whitening.
Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.).
Medical conditions considered by the researchers that may compromise the study or the individual safety of the patient.
Patients with poor oral hygiene.
Patients with previous hypersensitivity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel Giráldez, PhD
Phone
+34669119781
Email
isabel.giraldez@urjc.es
Facility Information:
Facility Name
Clínica Dental Iturralde
City
Tafalla
State/Province
Navarra
ZIP/Postal Code
31300
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan José Iturralde, dentistry
Phone
948 70 18 57
Email
iturralde@clinicadentaliturralde.com
First Name & Middle Initial & Last Name & Degree
Isabel Giráldez, PhD
First Name & Middle Initial & Last Name & Degree
Laura Ceballos, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22408775
Citation
Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9.
Results Reference
background
PubMed Identifier
35128627
Citation
Carneiro TS, Favoreto MW, Bernardi LG, Sutil E, Wendlinger M, Centenaro GG, Reis A, Loguercio AD. Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial. Clin Oral Investig. 2022 Jun;26(6):4381-4390. doi: 10.1007/s00784-022-04401-4. Epub 2022 Feb 7.
Results Reference
background
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At-home Bleaching Using Clear Aligners
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