Clínica Dental Iturralde
Tafalla, Navarre, 31300, Spain
NCT Number: NCT05835453
The aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Tafalla, Navarre, 31300, Spain
Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, essix-type retairner or Vivera retainer. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours The treatment lasted 4 weeks, although as each retainer was worn every other day, the actual application time was 2 weeks. Patient´s satisfaction will be evaluated at baseline, after one, two weeks, and 4 weeks with an apropriate questionnaire using a visual analog scale (EVA 0-10). The color will be assessed at baseline, after one, two and four weeks 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). 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria will be the following:
The exclusion criteria will be the following:
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 retainer, completing a total of 4 weeks of whitening procedure.
Time frame: Baseline, after one, two and four weeks
It will be measured with a questionnaire using a visual analog scale (EVA), when a essix-type retairner or Vivera retainer is used to perform a at home bleaching treatment with 10% carbamide peroxide.
Time frame: Baseline, after one, two and four weeks
The color will be assesed using subjetive color guides (VITA Classical and VITA 3D-MASTER) and a objetive digital spectrophotometer (VITA Easyshade).
Time frame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.
Time frame: Baseline, after one, two, four weeks, and at 1 month after bleaching treatment
They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide.
Universidad Rey Juan Carlos
Other
PATIENT SATISFACTION WITH AT-HOME DENTAL BLEACHING USING VIVERA OR ESSIX RETAINERS: A RANDOMIZED CLINICAL TRIAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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