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This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure, spanning from the 24-hour to the 1-year follow-up assessment periods.
Dental bleaching is a temporary treatment with potential adverse effects on dental sensitivity post-procedure. Therefore, the study aimed to evaluate dental color stability and sensitivity over a one-year period following bleaching, utilizing one of four desensitizing agents: PAMAM, MI Paste Plus, Hydroxyapatite and F (ReminPro), and Ultra EZ. The selection of the desensitizing agent was based on a predetermined randomization sequence generated in Microsoft Excel. Color stability was objectively assessed through spectrophotometric analysis, while subjective evaluation was conducted using the Vita Classic shade guide by two external observers not involved in the procedure. Dental sensitivity levels were tracked at various intervals using a visual analogue scale. Baseline measurements for both sensitivity and color stability were taken before the bleaching procedure, with subsequent evaluations at 24 hours, 3 days, 1 week, 1 month, 3 months, 6 months, 9 months, and 1 year post-bleaching. The study involved 60 patients from Ain Shams University seeking dental whitening treatment, divided into four groups based on the randomization sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly amido amine dendrimer (PAMAM)'s desensitizing agent | Experimental | Fourth generation with COOH terminal functional group, colorless liquid. PAMAM-succinamic acid dendrimer, 1,4-diaminobutane core, generation 4 solution. 10 wt.% in water. The application of PAMAM 30 min according to previous studies |
|
| Manufacturer's desensitizing agent, Ultra EZ | Experimental | 3% potassium nitrate and 0.11% fluoride (Ultra EZ), gel The application of manufacturer recommended desensitizing agent for 1hrs |
|
| MI paste plus, desensitizing agent | Experimental | Casein-phosphopeptide-amorphous calcium phosphate with Fluoride, topical tooth cream. Gel contains pure water,D-sorbitol,glycerol,Carboxymethylcellulose Sodium, casein phosphopeptide amorphous calcium phosphate,propylene glycol, titanium dioxide, Silicon dioxide, Sodium Saccharin,Phosphoric acid, butyl P-hydroxy-benzoate, and ethyl hydroxyl benzoate The application of MI paste plus according to manufacturer instructions, 3minutes |
|
| Hydroxyapatite and F (ReminPro), desensitizing agent | Experimental | Hydroxyapatite, Fluoride and Xylitol, water-based cream The application of Hydroxyapatite and F (ReminPro) according to manufacturer instructions, 3minutes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly amido amine dendrimer (PAMAM) | Other | Desensitizing agents was applied once after the bleaching procedure,as follows: 1-Bleaching/PAMAM group, patients received bleaching followed by the application of PAMAM for 30 minutes according to previous studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-bleaching dental hypersensitivity | Assessment will be carried out by a visual analogue scale (VAS), from 0 (no tooth sensitivity at all) to 10 (intolerable pain). Air blast stimulus will be used and will be applied on the tooth at distance of 0.5-1 cm for 2 seconds by the maximum power of the compressed air jet from the dental unit. Then sensitivity was measured before bleaching (baseline) and at each follow up period, 24 hours, 3 days, 7 days, 3 months, 6 months, 9 months, and one year post treatment | 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment |
| Shade stability | Assesment 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 the clinic lights with the dental unit light 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 assesment was carried out before bleaching and at each follow up periods, 24 hours, 3 days, 7 days, 3 months, 6 months, 9 months, and one year post treatment | 24 hours 3 days, 7 days, 1 month, 3 months, 6 months, 9 months and one year post treatment |
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Inclusion Criteria:
Male and female patients will be selected according to the following inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farid MS Al Askary, Professor | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry - Ain Shams University | Cairo | El Weili | 4393005 | Egypt |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 28, 2025 | |
| Reset | Sep 15, 2025 |
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This clinical study will be conducted to evaluate the effect of using 4th generation Poly amido amine dendrimer (PAMAM-COOH) as a desensitizing agent and compared with three different commercially available desensitizing materials: 3% potassium nitrate and 0.11% fluoride (Ultra EZ), as described by manufacturer, Casein-phosphopeptide-amorphous calcium phosphate with F, (MI paste plusTm), and Hydroxyapatite, Fluoride and Xylitol, Hydroxyapatite and F (ReminPro), on:
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This clinical trail was a double blinded trail in which 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 outcome assessors were blinded to the treatment that each participant had received
| Manufacturer's desensitizing agent, Ultra EZ | Other | Desensitizing agents was applied once after the bleaching procedure, as follows: 2-Control group, where patients received hydrogen peroxide in-office bleaching followed by the application of manufacturer recommended desensitizing agent ( Ultra EZ) once for 60 minutes. |
|
| MI paste plus, desensitizing agent | Other | Desensitizing agents was applied once after the bleaching procedure, as follows: 3-Bleaching/MI Paste Plus group, patients received bleaching followed by the application of MI paste plus according to the manufacturer's instructions once for 3 minutes. |
|
| Hydroxyapatite and F (ReminPro), desensitizing agent | Other | Desensitizing agents was applied once after the bleaching procedure, as follows: 4-Bleaching/Hydroxyapatite and F (ReminPro), patients received bleaching followed by the application of Hydroxyapatite and F (ReminPro) according to the manufacturer's instructions once for 3 minutes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 28, 2025 | Sep 15, 2025 |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017886 | Durapatite |
| ID | Term |
|---|---|
| D006882 | Hydroxyapatites |
| D001031 | Apatites |
| D002130 | Calcium Phosphates |
| D010710 | Phosphates |
| D010756 | Phosphoric Acids |
| D017976 | Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D008903 | Minerals |
| D017553 | Phosphorus Compounds |
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