Clinical trial NCT06358924: Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Hypersensitivity
Keywords: Dental Bleaching
Shade Stability
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-bleaching hypersensitivity
timeFrame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching
measure: Shade stability
timeFrame: 24 hours, 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post bleaching
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
state: El Weilli
Study officials:
affiliation: Faculty of Dentistry, Ain Shams University
name: Farid MS El-Askary, Professor
role: STUDY_DIRECTOR
References: