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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-13

Study Completion Date

2023-09-20

Brief Summary

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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.

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Detailed Description

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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

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Tooth Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This clinical study was conducted to evaluate the effect of using different desensitizing agents:

1. As recommended by manufacturer
2. Casein phosphopeptide-amorphous calcium phosphate/fluoride (CPP-ACPF) containing desensitizing agent
3. Hydroxyapatite/fluoride/xylitol containing desensitizing agent
4. Poly (amido amine) dendrimer with carboxylic acid terminal functional group containing desensitizing agent.

On patients subjected to bleaching procedure using hydrogen peroxide containing bleaching agent.

The clinical evaluation included:

1. Post-bleaching hypersensitivity.
2. Post-bleaching long-term shade stability.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This clinical trial was double blinded trial in which both the participant and outcome assessor were blinded to allocation, thus the participant was unaware of which experimental material had been assigned to him/her. Also the outcome assessors were blinded to the treatment that each participant had received.

Study Groups

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After whitening mousse

30 % Xylitol, 4.2 % potassium nitrate, and 1450 ppm fluoride. Topical tooth gel Gel was applied on bleached teeth for 10 minutes according to manufacturer's instructions.

Group Type EXPERIMENTAL

Potassium nitrate with fluoride

Intervention Type OTHER

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.

Mi Paste Plus

Casein-phosphopeptide-amorphous calcium phosphate with 0.2 % sodium fluoride (900ppm) Topical tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions

Group Type EXPERIMENTAL

Casein phosphopeptide-amorphous calcium phosphate with fluoride

Intervention Type OTHER

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.

Hydroxyapatite and Fluoride (ReminPro)

Hydroxyapatite (calcium and phosphate), ethanolic colophony, fluoride (1450 ppm NaF) and xylitol Topical water based tooth cream Cream was applied on bleached teeth for 3 minutes according to manufacturer's instructions

Group Type EXPERIMENTAL

Hydroxyapatite with fluoride

Intervention Type OTHER

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.

PAMAM "poly (amido amine)" dendrimer

PAMAM-succinamic acid dendrimer, 1,4-diaminobutane core, generation 4 solution. 10 wt.% in water Colorless liquid The liquid was applied on bleached teeth for 30 minutes (according to previous studies)

Group Type EXPERIMENTAL

PAMAM-carboxylic acid dendrimer

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants with their entire upper and lower teeth, from right first premolar to left first premolar, present and sound, without restorations or periodontal disease.
* The participants had low-caries index scores.
* Participants had teeth with a Vita-color shade of A2 or darker.
* Cooperative behavior patient and medically free.
* Patient ages between 18 to 40 years old

Exclusion Criteria

* Serious medically compromised patients.
* Smoking, alcoholism.
* Hypersensitivity to the agents used in the study.
* Lactating, pregnant patients.
* Patients with serious oral diseases, as acute necrotizing gingivitis, acute gingiva stomatitis, or those undergoing orthodontic treatment.
* Patients with dental enamel cracks.
* Patients who've had previous bleaching treatments

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes