Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371664
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-14
Brief Title:
Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment
Sponsor:
University of Santiago de Compostela
Organization:
University of Santiago de Compostela
Study Overview
Official Title:
Does the Use of a 3-mm Extended Tray During an At-home Bleaching Treatment Increases Gingival Irritation Associated With This Procedure in an Adult Patient Randomized Clinical Trial
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 primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation Additionally it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening
Detailed Description:
Visit 1 Study information and delivery of informed consent Recording of the patients 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 according to the predetermined assignment 1mm extended or 3 mm extended bleaching tray A positioning guide tray will be fabricated for color measurement
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 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 if they had gingival irritation and the degree of dental sensitivity
Visit 3 First-week bleaching review Data collection gingival irritation color sensitivity
Visit 4 Second-week bleaching review Data collection gingival irritation color sensitivity
Visit 5 Third-week bleaching review and end of the study Data collection gingival irritation color sensitivity
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 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 if they had gingival irritation and the degree of dental sensitivity
Visit 3 First-week bleaching review Data collection gingival irritation color sensitivity
Visit 4 Second-week bleaching review Data collection gingival irritation color sensitivity
Visit 5 Third-week bleaching review and end of the study Data collection gingival irritation 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?:
None