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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358924
Enrollment
48
Registered
2024-04-11
Start date
2021-11-13
Completion date
2023-09-20
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Hypersensitivity

Keywords

Dental Bleaching, Shade Stability

Brief 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.

Interventions

OTHERPotassium 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.

OTHERCasein 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.

OTHERHydroxyapatite 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.

OTHERPAMAM-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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-bleaching hypersensitivity24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleachingAssessment was carried out by a visual analogue scale (VAS), from 0 (no tooth sensitivity at all) to 10 (intolerable pain). The air stimulus was applied at a distance of 0.5-1 cm for 2 seconds by the maximum power of the compressed air jet from the dental unit. Then patients were asked to describe the intensity of pain by numbers from 1 to 10. Sensitivity was measured before bleaching (baseline) and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.
Shade stability24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleachingAssessment was carried out using Vita Easy-Shade V. Two measurements were taken for each tooth from the upper right canine to the upper left canine, and same for the lower arch. For light condition standardization, all shade measurements were carried out under natural daylight in combination with constant artificial light sources; the clinic overhead lights in combination with the dental unit light directed away from the patient. The shade of each tooth was recorded as well as the values of L, a, and b. The shade of the upper two centrals was confirmed using Vita classical shade guide. Shade assessment was carried out before bleaching, and at each follow up period, 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026