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Completed

NCT Number: NCT06358924

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

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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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, El Weilli, 4393005, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potassium nitrate with fluoride

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.

Casein phosphopeptide-amorphous calcium phosphate with fluoride

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 with fluoride

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-carboxylic acid dendrimer

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.

Primary outcomes

  1. Post-bleaching hypersensitivity

    Time frame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching

    Assessment 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.

  2. Shade stability

    Time frame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching

    Assessment 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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