Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614764
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Effect of Andiroba on Control of Post-whitening Tooth Sensitivity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Andiroba on Control of Post-whitening Tooth Sensitivity a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil Carapa guianensis in reducing postoperative tooth sensitivity caused by bleaching with 35 hydrogen peroxide Volunteers in this study will be randomized into 3 different groups - PG placebo gel KF2G potassium nitrate gel and AG andiroba gel Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel respectively This will be applied to the buccal surfaces of the central incisors lateral incisors canines and upper and lower premolars with a rubber cup in an active manner for 10 minutes Group GP will receive the application of a placebo gel without active ingredient under the same conditions described for the other groups Subsequently all groups will undergo in-office bleaching treatment with 35 hydrogen peroxide Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale VAS Color measurement will be performed with a spectrophotometer at two times baseline T0 and one week after the 3rd bleaching session T1
Detailed Description:
All groups will undergo in-office whitening treatment carried out in 3 sessions with a 7-day interval according to the steps described below
Prophylaxis Application of gingival barrier Application of desensitizing agent or placebo according to the established groups Handling of the whitening material following the manufacturers instructions application of Whiteness HP 35 whitening gel for 15 minutes each totaling 45 minutes Final removal of the whitening gel and gingival barrier followed by rinsing with water
The application of the desensitizing agent or its placebo will follow this sequence
Relative isolation with cotton rolls Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes Rinsing with water
Prophylaxis Application of gingival barrier Application of desensitizing agent or placebo according to the established groups Handling of the whitening material following the manufacturers instructions application of Whiteness HP 35 whitening gel for 15 minutes each totaling 45 minutes Final removal of the whitening gel and gingival barrier followed by rinsing with water
The application of the desensitizing agent or its placebo will follow this sequence
Relative isolation with cotton rolls Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes Rinsing with water
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None