NCT06358924

Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability

The Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity, Shade Stability and Surface Properties of Bleached Enamel. An In-vitro and In-vivo Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year.

Detailed description

This study was conducted to assess the effectiveness of 4 different desensitizing agents used after dental bleaching regarding dental hypersensitivity and shade stability. It was a double-blinded randomized clinical trial. The ethical approval was obtained in May 2020 by the Research Ethics Committee an Institutional Review Board, Faculty of Dentistry, Ain Shams University (FDASU-REC). The number of patients was determined according to G-Power program with a power (1-β error) of 0.8 (Power = 80%), and 95% confidence level (α = 0.05) using a two-sided hypothesis test. According to sample size calculation, 40 patients were needed for this study (n=10 per group). Patients were selected according to inclusion and exclusion criteria and were randomly assigned into 4 groups according to the desensitizing agent used. The 4 desensitizing agents were: After Whitening Mousse, Mi Paste Plus, Hydroxyapatite and Fluoride (ReminPro) and PAMAM. Patients signed an informed consent and received a detailed explanation of the study procedures. Baseline dental shade was recorded using Vita Easy-Shade spectrophotometer and Vita Classical Shade guide. Baseline sensitivity was assessed and recorded using a VAS. All patients received dental bleaching using In-office chemically activated Power Whitening YF (WHITEsmile, Germany) followed by a desensitizing procedure using the desensitizing agent assigned to the specific experimental group. Dental shade and dental hypersensitivity was assessed at different follow-up appointments; 24-hours, 3 days, 1 week, 1 month, 3 months, 6 months, 9 months and 1 year following the procedures. Assessment of these variables at follow-up appointments was performed by 2 external assessors, and patients were blinded to the type desensitizing agent used.

Conditions

• Tooth Hypersensitivity

Interventions

Type	Name	Description
OTHER	Potassium nitrate with fluoride	Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of the desensitizing agent recommended by the manufacturer (After Whitening Mousse), once for 10 minutes.
OTHER	Casein phosphopeptide-amorphous calcium phosphate with fluoride	Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Mi Paste Plus once for 3 minutes.
OTHER	Hydroxyapatite with fluoride	Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of Hydroxyapatite and Fluoride (ReminPro) once for 3 minutes.
OTHER	PAMAM-carboxylic acid dendrimer	Bleaching of teeth using in-Office chemically-activated bleaching agent (Power Whitening YF) was performed followed by the application of PAMAM once for 30 minutes.

Timeline

• Start date: 2021-11-13
• Primary completion: 2023-08-25
• Completion: 2023-09-20
• First posted: 2024-04-11
• Last updated: 2024-04-23

Locations

1 site across 1 country: Egypt