Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide

Study Overview
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Brief Summary
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Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with At-Home vital tooth whitening using 20% carbamide peroxide

Detailed Description
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Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide 4h/day for a week, the sample will be divided into two groups : the experimental group will apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment, the control group will apply placebo paste 30 min/day after bleaching treatment,

Official Title
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Effect of Tri Calcium Phosphate Paste on Efficacy and Postoperative Sensitivity Associated With At-Home Vital Tooth Whitening Using 20% Carbamide Peroxide 'A Randomized Controlled Study'

Conditions
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Tooth Sensitivity

Intervention / Treatment
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* Other: Tri-calcium Phosphate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good dental health Six maxillary anterior teeth present and healthy with no restorations or carious lesions Teeth darker than Vita A2 shade No history of teeth sensitivity No use of a desensitizing agent or desensitizing toothpaste in the past three months Exclusion Criteria: Active caries or periodontal disease Allergies to bleaching agent or tray material pregnancy and breastfeeding during the trial tetracycline-stained teeth or fluoride or non-vital teeth Smoker Using tooth bleaching products during the last 3 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tri-calcium Phosphate<br>clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20% | Other: Tri-calcium Phosphate<br>* A paste contains Tri Calcium Phosphate & Fluoride<br>* Other names: ( Clinpro™ Tooth Crème, 3M ESPE, USA;|
| Placebo Comparator: Placebo<br>a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20% | Other: Placebo<br>* paste manufactured to mimic Clinpro, without Tri Calcium Phosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sensitivity Status | using a visual analog scale (VAS) | at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Color Shade | color shade change will be detected; using Vita Easy Shadeِ Advance 4.0. | at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tooth sensitivity, tri calcium phosphate, at-home whitening