Ignite Creation Date:
2024-05-06 @ 1:44 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04112706
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2019-09-24
Brief Title:
Efficacy of CPP-ACP on Bleaching Related Sensitivity
Sponsor:
University of New England
Organization:
University of New England
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2019-09
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:
Objective The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching
Methods 45 subjects were randomly divided into two groups based upon which arch received MI Paste Group 1 bleached Maxillary arch Group 2 bleached mandibular arch Two weeks later subjects stopped bleaching the first arch and started second arch Sensitivity was measured by VAS daily log scale for two weeks Shade was taken with colorimeter and Classic Vita shade guide at baseline immediate post-bleaching and two weeks post-bleaching Longitudinal sensitivity over the 14 days period of bleaching was summarized The Wilcoxon Signed Rank test was used to compare summary measures
Methods 45 subjects were randomly divided into two groups based upon which arch received MI Paste Group 1 bleached Maxillary arch Group 2 bleached mandibular arch Two weeks later subjects stopped bleaching the first arch and started second arch Sensitivity was measured by VAS daily log scale for two weeks Shade was taken with colorimeter and Classic Vita shade guide at baseline immediate post-bleaching and two weeks post-bleaching Longitudinal sensitivity over the 14 days period of bleaching was summarized The Wilcoxon Signed Rank test was used to compare summary measures
Detailed Description:
Study Design
This was a randomized controlled split-mouth cross-over design clinical trial Subjects were randomized into two groups depending on the control and intervention arches
Group 1 The maxillary arch was the control arch only bleaching while the mandibular arch MN was intervention arch bleaching and MI Paste
Group 2 The MN arch was the control arch only bleaching while the MX arch was the intervention arch bleaching and MI Paste
Ethical permission for the study was obtained from the University Intuitional Review Board No 200604706 The study was conducted in full accordance with the Helsinki Declaration and reported using CONSORT guidelines Informed consents were obtained from the subjects prior to enrolment in the study
Participants Forty-six participants were recruited at the Oral Health Center Participants were included if they age between 18 and 55 years old with no prior history of bleaching not using any desensitizing agents and with anterior teeth of shade A2 or higher Participants allergic to milk protein pregnant andor on daily NSAIDs were excluded They were also excluded if they have had an anterior crown or composite restoration scaling or periodontal surgery performed in the past six months andor had a history of bleaching
Intervention Both the bleaching gel TiON whitening gel GC America Inc and MI paste PROSPECTM MI paste were delivered using custom trays with reservoir made for participants at the beginning of the study To avoid contamination the control arch was always bleached first Group 1 subjects were instructed to use 15 carbamide peroxide on maxillary arch while group 2 were instructed to use it on the mandibular arch Subjects stopped bleaching on their respective arches after 2 weeks Subjects were then given bleach and MI paste to be used on the opposing arch Group 1 used it on the mandibular arch and Group 2 used it on maxillary arch
For bleaching only arch participants were instructed to wear the trays each night for 6-8 hours for two weeks Subjects were given a VAS daily log to document the sensitivity for two weeks For bleach and MI Paste arch participants were instructed to brush and floss their teeth load the non-scalloped tray with MI Paste wear it for 5 minutes remove the tray spit out the excess and not to eat or drink for one hour They were instructed to bleach after that for 6-8 hours for the next two weeks Participants were instructed not to bleach the first arch anymore Participants were given a VAS daily log to document the sensitivity score for each day for two weeks
Measurements Measurements were made at baseline Time 0 2 weeks after initiation of bleaching Time 1 and 2 weeks after the end of treatment ie 4 weeks after initiation of bleaching Time 2 for each arch Longitudinal VAS scores were to be assessed at baseline Day 0 and daily during the two weeks of bleaching Days 1 through 14
Sensitivity Sensitivity was measured using thermal sensitivity scale VAS of 0-10 with 0 being no pain and 10 being severe pain Subjects were asked to pick a number Thermal sensitivity was measured by using a 1-second air blast at 70oF from dental unit air syringe as per American Dental Association ADA guidelines A Scale of 0-3 was used to measure the pain response with 0 indicating no pain and 3 indicating the severe pain which lasted for more than 10 seconds12
Shade Value-oriented Vita classical shade guide was used to determine the shade of the teeth under standardized conditions for color corrected light Shade scores were ordered from 1 to 16 according to the brightness grouping recommended by the manufactures A hand held coloriometer Shade Vision X-rite Inc was used to measure shade digitally Shade Vision identifies color difference using three dimensional CIE Lab values system
Participants Survey Participants were given a survey at the end of the study examining their perception on the ease of application of MI Paste as well as the impact of MI Paste on sensitivity and gingival inflammation
This was a randomized controlled split-mouth cross-over design clinical trial Subjects were randomized into two groups depending on the control and intervention arches
Group 1 The maxillary arch was the control arch only bleaching while the mandibular arch MN was intervention arch bleaching and MI Paste
Group 2 The MN arch was the control arch only bleaching while the MX arch was the intervention arch bleaching and MI Paste
Ethical permission for the study was obtained from the University Intuitional Review Board No 200604706 The study was conducted in full accordance with the Helsinki Declaration and reported using CONSORT guidelines Informed consents were obtained from the subjects prior to enrolment in the study
Participants Forty-six participants were recruited at the Oral Health Center Participants were included if they age between 18 and 55 years old with no prior history of bleaching not using any desensitizing agents and with anterior teeth of shade A2 or higher Participants allergic to milk protein pregnant andor on daily NSAIDs were excluded They were also excluded if they have had an anterior crown or composite restoration scaling or periodontal surgery performed in the past six months andor had a history of bleaching
Intervention Both the bleaching gel TiON whitening gel GC America Inc and MI paste PROSPECTM MI paste were delivered using custom trays with reservoir made for participants at the beginning of the study To avoid contamination the control arch was always bleached first Group 1 subjects were instructed to use 15 carbamide peroxide on maxillary arch while group 2 were instructed to use it on the mandibular arch Subjects stopped bleaching on their respective arches after 2 weeks Subjects were then given bleach and MI paste to be used on the opposing arch Group 1 used it on the mandibular arch and Group 2 used it on maxillary arch
For bleaching only arch participants were instructed to wear the trays each night for 6-8 hours for two weeks Subjects were given a VAS daily log to document the sensitivity for two weeks For bleach and MI Paste arch participants were instructed to brush and floss their teeth load the non-scalloped tray with MI Paste wear it for 5 minutes remove the tray spit out the excess and not to eat or drink for one hour They were instructed to bleach after that for 6-8 hours for the next two weeks Participants were instructed not to bleach the first arch anymore Participants were given a VAS daily log to document the sensitivity score for each day for two weeks
Measurements Measurements were made at baseline Time 0 2 weeks after initiation of bleaching Time 1 and 2 weeks after the end of treatment ie 4 weeks after initiation of bleaching Time 2 for each arch Longitudinal VAS scores were to be assessed at baseline Day 0 and daily during the two weeks of bleaching Days 1 through 14
Sensitivity Sensitivity was measured using thermal sensitivity scale VAS of 0-10 with 0 being no pain and 10 being severe pain Subjects were asked to pick a number Thermal sensitivity was measured by using a 1-second air blast at 70oF from dental unit air syringe as per American Dental Association ADA guidelines A Scale of 0-3 was used to measure the pain response with 0 indicating no pain and 3 indicating the severe pain which lasted for more than 10 seconds12
Shade Value-oriented Vita classical shade guide was used to determine the shade of the teeth under standardized conditions for color corrected light Shade scores were ordered from 1 to 16 according to the brightness grouping recommended by the manufactures A hand held coloriometer Shade Vision X-rite Inc was used to measure shade digitally Shade Vision identifies color difference using three dimensional CIE Lab values system
Participants Survey Participants were given a survey at the end of the study examining their perception on the ease of application of MI Paste as well as the impact of MI Paste on sensitivity and gingival inflammation
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?:
False
Is an FDA AA801 Violation?:
None