School of Medicine and Dentistry
Santiago de Compostela, A Coruña, 15705, Spain
NCT Number: NCT07355647
The main objective of this study is to evaluate if the use of a desensitizing agent (UltraEZ) during in-office bleaching treatment is effective in reducing tooth sensitivity , as well as doesn't affect the degree of tooth bleaching.
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Notify Me18 year–99 year
All sexes
Interventional
Early Phase 1
Santiago de Compostela, A Coruña, 15705, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. Application of the UltraEZ in the bleaching trays for 30 minutes. Isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes
General Examination with bite-wings, dental prophylaxis, alginate impressions of both arches, creation of individualized bleaching trays and position finder trays. Application of the placebo in the bleaching trays for 30 minutes. Isolation of the gingival tissues. Two applications of the bleaching agent of 20 minutes
Time frame: Perioperative, 1 hour postoperative, 24 hours postoperative, 48 hours postoperative
General tooth sensitivity was assessed using a 5-point Numeric Rating Scale (NRS), where 0 = no sensitivity; 1 = mild discomfort; 2 = moderate discomfort that does not interfere with daily activities; 3 = considerable discomfort leading to avoidance of certain foods and beverages; and 4 = severe sensitivity requiring interruption of the bleaching treatment. Participants selected the numeric value that best represented their perceived level of tooth sensitivity.
Pain intensity was recorded at the following time points:
Time frame: Baseline (Bleaching Day 1), 1 week later baseline (Before Bleaching day 2), Revision (One week after second bleaching session)
Tooth color will be measured using a dental spectrophotometer, recording the following parameters: L (lightness, representing the shade from black to white on a scale of 0 to 100), a (color variation along the red-green axis, with positive values toward red/purple and negative values toward green/blue), b (color variation along the yellow-blue axis, with positive values toward yellow and negative values toward blue/purple), C (chroma, describing the intensity or saturation of a color, expressed on a scale from 0 to 40, where 0 indicates no saturation and 40 the maximum saturation), and hº (hue, representing the dominant wavelength of a color on a continuous circular scale from 0° to 360°).
Color changes between visits will be calculated using the CIELab, CIEDE2000, and White Index for Dentistry (WID) formulas.
Color measurements will be recorded at the following time points:
University of Santiago de Compostela
Other
A Triple Blind Randomized Clinical Trial Comparing the Efficacy of a Desensitizing Agent Used With an In-Office Bleaching Technique
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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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