Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 6:29 PM
Study NCT ID:
NCT06371092
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Desensitizing Agent During At-home Bleaching
Sponsor:
University of Santiago de Compostela
Organization:
Study Overview
Official Title:
A Triple-blind Randomized Clinical Trial Comparing the Efficacy of a Desensitizing Agent Used With an At-home Bleaching Technique
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching.
Detailed Description:
1. Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient. A positioning guide tray will be fabricated for color measurement.
2. Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products) and one syringe of desensitizing agent (UltraEZ, Ultradent Products) or placebo (glycerin), according to their study group. Both the desensitizing agent and placebo will be dispensed in identical syringes, coded as A and B, to ensure the blinding of the study; only the clinician responsible for randomization knows the coding. Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record the degree of dental sensitivity .
3. Visit 3: First-week bleaching review. Data collection (color + sensitivity).
4. Visit 4: Second-week bleaching review. Data collection (color + sensitivity).
5. Visit 5: Third-week bleaching review and end of the study. Data collection (color + sensitivity).
2. Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products) and one syringe of desensitizing agent (UltraEZ, Ultradent Products) or placebo (glycerin), according to their study group. Both the desensitizing agent and placebo will be dispensed in identical syringes, coded as A and B, to ensure the blinding of the study; only the clinician responsible for randomization knows the coding. Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record the degree of dental sensitivity .
3. Visit 3: First-week bleaching review. Data collection (color + sensitivity).
4. Visit 4: Second-week bleaching review. Data collection (color + sensitivity).
5. Visit 5: Third-week bleaching review and end of the study. Data collection (color + sensitivity).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: