Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-27
Brief Title:
Evaluation of In-office Bleaching-induced Sensitivity With 2 or 7 Days Interval Between Sessions
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Evaluation of In-office Bleaching-induced Sensitivity With 2 or 7 Days Interval Between Sessions
Status:
ACTIVE_NOT_RECRUITING
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:
Clinical randomized single-blind trial used to measure the level of tooth sensitivity TS after in-office dental bleaching sessions on volunteers using a modified visual analog scale VAS We selected for this study 47 patients with color 2M2 or darker Using 0M1 - 5M3 Vita bleaching shade guide We performed two bleaching sessions with an acidic 35 hydrogen peroxide gel with either a 1-week or 2-day interval We recorded the TS up to 48 h with a VAS scale and the color at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer The risk and intensity of TS and the color change were compared between the two groups
Detailed Description:
Two weeks before the bleaching procedures selected volunteers from the city of Nova Friburgo Rio de Janeiro Brazil received a dental screening and a dental prophylaxis with pumice and water in a rubber cup and signed an informed consent form
This was a randomized single-blind evaluators parallel and equivalence trial with an equal allocation rate between groups
A total of 61 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria A total of 47 patients were included in this study They were randomly divided the participants in the 2-day and 7-day groups
During the in-office sessions participants had the gingival tissue isolated of the teeth using a light-cured resin dam Top Dam FGM Joinville SC Brazil After that a 2 Potassium nitrate and Sodium fluoride desensitizer gel Desensitize 2 FGM was applied for 15 minutes before dental bleaching This gel was removed and the 35 hydrogen peroxide gel Whiteness HP FGM Joinville Brazil was applied in three 15-min applications according to the manufacturers directions in all upper and lower incisors canines and premolars After 2 days 2-day group and 7 days 7-day group this procedure was repeated using the same protocol
Color evaluation was performed before and 30 days after the end of the bleaching treatment using a subjective value oriented shade guide Vita Lumin Vita Zahnfabrik Bad Sackingen Germany and an objective method Easyshade spectrophotometer Vident Brea CA USA Color evaluation was done in a room under artificial lightning conditions without interference from outside light
For the subjective examination the shadeguides 16 tabs were arranged from highest B1 to lowest C4 value Changes in the scale were treated as representing a continuous and approximately linear ranking Color was measured in the middle third of the facial surface of the right upper canine at baseline and 30 days after bleaching to calculate the variations in color towards the lighter end of the scale Delta Shade Guide Units - DSGU
One calibrated operator measured the colour in all participants using the Vita Easyshade spectrophotomer Easyshade Vident Brea CA USA before and 30 days after the bleaching therapy The L a and b parameters were recorded L represents the value from 0 black to 100 white and a and b represent the shade where a is the measurement along the red-green axis and b is the measurement along the yellow-blue axis Color change was calculated between the two assessment periods DE using the formula DE DL2 Da2 Db212
The patients recorded their perception of TS during the first and second bleaching sessions using the visual analogue scale VAS This scale employs a 10-cm horizontal line with words no pain at one end and worst pain at the opposite end Participants recorded whether they experienced TS during the treatment up to 1 h after the bleaching from 1 h to 24 h and from 24 h to 48 h after bleaching In the 30-day recall patients were also asked if they experienced pain during this 30-day period As two bleaching sessions were performed the VAS score obtained in both bleaching sessions was considered for statistical purposes These values were computed for the maxillary arch
This was a randomized single-blind evaluators parallel and equivalence trial with an equal allocation rate between groups
A total of 61 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria A total of 47 patients were included in this study They were randomly divided the participants in the 2-day and 7-day groups
During the in-office sessions participants had the gingival tissue isolated of the teeth using a light-cured resin dam Top Dam FGM Joinville SC Brazil After that a 2 Potassium nitrate and Sodium fluoride desensitizer gel Desensitize 2 FGM was applied for 15 minutes before dental bleaching This gel was removed and the 35 hydrogen peroxide gel Whiteness HP FGM Joinville Brazil was applied in three 15-min applications according to the manufacturers directions in all upper and lower incisors canines and premolars After 2 days 2-day group and 7 days 7-day group this procedure was repeated using the same protocol
Color evaluation was performed before and 30 days after the end of the bleaching treatment using a subjective value oriented shade guide Vita Lumin Vita Zahnfabrik Bad Sackingen Germany and an objective method Easyshade spectrophotometer Vident Brea CA USA Color evaluation was done in a room under artificial lightning conditions without interference from outside light
For the subjective examination the shadeguides 16 tabs were arranged from highest B1 to lowest C4 value Changes in the scale were treated as representing a continuous and approximately linear ranking Color was measured in the middle third of the facial surface of the right upper canine at baseline and 30 days after bleaching to calculate the variations in color towards the lighter end of the scale Delta Shade Guide Units - DSGU
One calibrated operator measured the colour in all participants using the Vita Easyshade spectrophotomer Easyshade Vident Brea CA USA before and 30 days after the bleaching therapy The L a and b parameters were recorded L represents the value from 0 black to 100 white and a and b represent the shade where a is the measurement along the red-green axis and b is the measurement along the yellow-blue axis Color change was calculated between the two assessment periods DE using the formula DE DL2 Da2 Db212
The patients recorded their perception of TS during the first and second bleaching sessions using the visual analogue scale VAS This scale employs a 10-cm horizontal line with words no pain at one end and worst pain at the opposite end Participants recorded whether they experienced TS during the treatment up to 1 h after the bleaching from 1 h to 24 h and from 24 h to 48 h after bleaching In the 30-day recall patients were also asked if they experienced pain during this 30-day period As two bleaching sessions were performed the VAS score obtained in both bleaching sessions was considered for statistical purposes These values were computed for the maxillary arch
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None