Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532526
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Effects of Bio-active Desensitizer on Reduction of Tooth Sensitivity Caused by In-office Bleaching
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of the Effects of Bio-active Desensitizing Materials on the Bleaching Efficacy and Reduction of Tooth Sensitivity Caused by Vital In-office Bleaching A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The main aim of this randomized controlled clinical trial is to evaluate the efficacy of a bioactive glass desensitizer in reducing tooth sensitivity associated with in-office vital tooth bleaching In addition this study aims to compare the effectiveness of the bioactive glass desensitizer with that of a fluoride gel and a gel without desensitizing agent with regard to incidence intensity and duration of tooth sensitivity and finally to investigate how these agents affect tooth-shade following in-office bleaching The hypothesis of the study is There will be no difference in the effect of a bio-active glass desensitizer on tooth sensitivity associated with vital in-office tooth bleaching compared to a fluoride gel and the bio-active glass desensitizer has no effect on the bleaching efficacy
Detailed Description:
The participants will be informed about the nature and objectives of the study however they will not be informed what desensitizing material they would receive The study will be a double blinded Patient and evaluator randomized clinical trial with a sample size of 51 17 participants for each group n17 Bleaching process A lip and cheek retractor will be placed The gingival tissues from the right first molar to the left first molar will be isolated using a light-cured resin dam to prevent the whitening gel from coming into contact with the gingival tissue Participants lips will be painted with Vaseline and protective eyewear will be used To aid in the isolation process a plastic suction tip with high suction power will be used Opalescence Boost in Office Whitening Gel 40 Hydrogen Peroxide bleaching material Ultradent Products South Jordan UT USA will be applied directly on the labial tooth surface from the right first premolar to the left first premolar A total of three 20-minute applications will be completed in each bleaching session Participants will undergo 2 bleaching sessions with one-week interval Participants will be scheduled for lower arch whitening after 14 days
Application of the desensitizer The participants will be assigned randomly to three study groups The first group will receive a bio active desensitizer the second group will receive a fluoride gel and the third group will receive a placebo gel without a desensitizer Table 2 A small amount of the gel assigned for each participant will be applied directly on the labial surface of each tooth and left undisturbed for three minutes care will be taken to cover the entire labial surface and the gel will be carried interproximally as much as possible
Shade evaluation Teeth shade will be evaluated subjectively and objectively Subjectively it will be evaluated using VITA classical shade guide which has 16 tabs ranging from B1 lightest value to C4 darkest value by matching the color with the middle third of the maxillary anterior teeth One evaluator will record the shade of the participants teeth at baseline before whitening directly after bleaching and at days 3 7 and 14 days follow up periods Photographs will be taken using a digital camera immediately after the whitening and at each shade evaluation to document results Also teeth shade will be evaluated objectively using VITA easy shade spectrophotometer VITA Easyshade V VITA Zahnfabrik Bad Sackingen Germany The tooth must be well hydrated before analyzing the tooth color The shade of the teeth in VITA classical A1-D4 and VITA 3D-MASTER shades will be instantly measured and displayed on the screen One evaluator will record the shade of the teeth and the shade will be recorded at baseline immediately after bleaching and at 3 7 and 14 days follow up periods Sensitivity Evaluation Post-bleaching sensitivity will be evaluated by relying on patients feeling of pain
Sensitivity evaluation All participants will be given a sensitivity sheet to record the post-whitening sensitivity of the whitened teeth on daily basis up to 14 days according to the visual analog scale of pain VAS The participants will be asked to record the stimulus that caused sensitivity including hot cold or other The duration of pain whether seconds minutes or hours will be recorded for the 14-day follow-up period
Application of the desensitizer The participants will be assigned randomly to three study groups The first group will receive a bio active desensitizer the second group will receive a fluoride gel and the third group will receive a placebo gel without a desensitizer Table 2 A small amount of the gel assigned for each participant will be applied directly on the labial surface of each tooth and left undisturbed for three minutes care will be taken to cover the entire labial surface and the gel will be carried interproximally as much as possible
Shade evaluation Teeth shade will be evaluated subjectively and objectively Subjectively it will be evaluated using VITA classical shade guide which has 16 tabs ranging from B1 lightest value to C4 darkest value by matching the color with the middle third of the maxillary anterior teeth One evaluator will record the shade of the participants teeth at baseline before whitening directly after bleaching and at days 3 7 and 14 days follow up periods Photographs will be taken using a digital camera immediately after the whitening and at each shade evaluation to document results Also teeth shade will be evaluated objectively using VITA easy shade spectrophotometer VITA Easyshade V VITA Zahnfabrik Bad Sackingen Germany The tooth must be well hydrated before analyzing the tooth color The shade of the teeth in VITA classical A1-D4 and VITA 3D-MASTER shades will be instantly measured and displayed on the screen One evaluator will record the shade of the teeth and the shade will be recorded at baseline immediately after bleaching and at 3 7 and 14 days follow up periods Sensitivity Evaluation Post-bleaching sensitivity will be evaluated by relying on patients feeling of pain
Sensitivity evaluation All participants will be given a sensitivity sheet to record the post-whitening sensitivity of the whitened teeth on daily basis up to 14 days according to the visual analog scale of pain VAS The participants will be asked to record the stimulus that caused sensitivity including hot cold or other The duration of pain whether seconds minutes or hours will be recorded for the 14-day follow-up period
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