The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching

Study Overview
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Brief Summary
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Tooth whitening is a procedure that has been increasingly requested by patients around the world, whether at home or in office bleaching. Tooth sensitivity is the main side effect of bleaching. It have a great power to interfere negatively in the quality of life of those affected. According to the literature, about 51% of people who had at-home bleaching developed postoperative sensitivity. The objective of this clinical, randomized, double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching, with 22% carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis. For develop this study, 50 patients will be selected, with no previous history of sensitivity, aged between 18 and 30 years. They will be divided into four treatment groups: PLACEBO group; CPP-ACPF group; LASER group; LASER+CPP-ACPF group. Home bleaching treatment will use 22% carbamide peroxide. Patients should use two hours a day for 21 days. The desensitizing treatments will be applied in four moments, according to the group of each patient: before starting the bleaching treatment; after one week of the bleaching treatment; after two weeks of whitening treatment and after three weeks of whitening treatment. Sensitivity will be assessed using a visual analogue scale (VAS), where patients should daily mark their pain level (from 0 to 10) on each side of the arcade. After the 21 days of treatment, they will receive a new VAS, to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment. In parallel with bleaching treatment and sensitivity treatment, the color analysis of teeth 13, 11, 21 and 23 will be performed, with the Vita Easyshade Advance 4.0 spectrophotometer, to monitor the bleaching performance, in each week. The first one will occur before starting the bleaching treatment (baseline) and a new measurement will be performed every week, together with the application of treatments for sensitivity. The collected data will be tabulated in an Excel Microsoft Windows 2010) spreadsheet and analyzed in the Jamovi 1.6.23 (The Jamovi Project, 2020) software. For inter- and intra-group analysis of sensitivity values, the Repeated Measures statistical test will probably be used. For all statistical analyses, a significance level of 5% will be adopted.

Detailed Description
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Tooth whitening is a procedure that has been increasingly requested by patients around the world, whether at home or in office bleaching. Tooth sensitivity is the main side effect of bleaching. It have a great power to interfere negatively in the quality of life of those affected. According to the literature, about 51% of people who had at-home bleaching developed postoperative sensitivity. The objective of this clinical, randomized, double-blind study is to evaluate the effectiveness of the association of casein phosphopeptides-fluoridated amorphous calcium phosphate with photobiomodulation in the treatment of tooth sensitivity after home bleaching, with 22% carbamide peroxide and also evaluate the effectiveness of at home bleaching through color analysis. Fifty patients will be selected, who will be divided into four treatment groups: PLACEBO group (will receive a LASER simulation and a manipulated paste without active ingredient to simulate the CPP-ACPF paste); CPP-ACPF group (will receive the CPP-ACPF folder and a LASER simulation); LASER group (will receive the LASER and a manipulated paste without active ingredient to simulate the CPP-ACPF paste); LASER+CPP-ACPF group (will receive the LASER and the CPP-ACPF folder). As it is a split-mouth study, each patient will receive two different types of treatment, one on each side of the arches, thus, the sample size of each group will be 25 patients (n=25). The treatment with the CPP-ACPF paste (MI paste plus) will be carried out in the CPP-ACPF and LASER+CPP-ACPF groups, at the following times: before the bleaching treatment (T0), after one week of bleaching (T1), after two weeks of bleaching (T2), after three weeks of bleaching (T3). The application will be made on the buccal surfaces of the teeth, up to the second premolars, with the aid of a microbrush applicator (Microbrush, 3M Espe), for five minutes. Afterwards, patients will be instructed to spit out the excess and avoid ingesting anything for 30 minutes. In the PLACEBO group, this clinical protocol will be performed exactly, but using the paste without active ingredient. The LASER and CPP-ACPF+FBM groups will receive the application of LASER (Therapy EC, DMC, São Carlos, SP, Brazil), using the infrared light spectrum with a wavelength of 808 nm with its active medium of Arsento Gallium and Aluminum (AsGaAl), at three points, one in the center of the crown of the tooth, another in the center of the cervical region and the last one in the incisal region, with the light beam directed apically, from all teeth to the second premolar of each hemi -upper and lower arch. The energy used was 1 Joule per point for 10 seconds. While the PLACEBO and CPP-ACPF groups received a LASER simulation. The sounds emitted by the laser during its use will be simulated by a mobile application. All study participants will receive a tube of bleaching agent (Whiteness Simple 22%, FGM, Joinville, Brazil) and will be instructed to apply a drop of the product on the vestibular surface of each tooth on the whitening tray (up to the second premolars) and use for two uninterrupted hours for 21 days. Sensitivity will be assessed using a visual analogue scale (VAS), where patients should daily mark their pain level (from 0 to 10) on each side of the arcade. After the 21 days of treatment, they will receive a new VAS, to evaluate if was any sensitivity will occur during 30 days after the bleaching treatment. In parallel with bleaching treatment and sensitivity treatment, the color analysis of teeth 13, 11, 21 and 23 will be performed, with the Vita Easyshade Advance 4.0 spectrophotometer, to monitor the bleaching performance, in each week. The first one will occur before starting the bleaching treatment (baseline) and a new measurement will be performed every week, together with the application of treatments for sensitivity. The collected data will be tabulated in an Excel Microsoft Windows 2010) spreadsheet and analyzed in the Jamovi 1.6.23 (The Jamovi Project, 2020) software. For inter- and intra-group analysis of sensitivity values, the Repeated Measures statistical test will probably be used. For all statistical analyses, a significance level of 5% will be adopted.

Official Title
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Effectiveness of Association of Casein Phosphopeptides-fluoridated Amorphous Calcium Phosphate Associated With Photobiomodulation in the Treatment of Tooth Sensitivity After Home Bleaching: A Randomized, Split-mouth Clinical Trial

Conditions
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Sensitivity, Tooth

Intervention / Treatment
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* Radiation: Laser of low frequncy
* Drug: CPP-ACPF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 30 years; Good general and oral health; Sound incisors, canines and premolars; Prior whitening treatment; No hypersensitivity; Exclusion Criteria: Patients undergoing fixed orthodontic treatment; Presence of periodontal disease; Presence of cracks or fractures; Presence of restorations and prostheses in anterior teeth; Extensive restorations in molars; Presence of gastroesophageal dysfunctions; Patients with severe internal dental darkening; Presence of exposed dentin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| Placebo Comparator: CPP-ACPF PASTE APLICATION<br>Apply the cpp-acpf paste, at four different times (one each week of whitening treatment), for five minutes in each application and evaluate if it was able to reduce the sensitivity after home whitening with 22% carbamide peroxide. | Drug: CPP-ACPF<br>* Apply MI paste plus for five minutes, in the vestibular surface os teeth. During this time patientes should be with closed mounth ad should not talk or to split.<br>* Other names: MI paste plus;|
| No Intervention: Evaluate the effectiviness at home bleaching<br>To evaluate the effectiveness of at-home bleaching with 22% carbamide peroxide, with the help of the VITA Easyshade 4.0 spectrophotometer | |
| Placebo Comparator: LASER APLICATION<br>Apply the laser at four different times (one every week of whitening treatment), using the spectrum of infrared light with a wavelength of 808 nm with its active medium of Arsento Gallium and Aluminum (AsGaAl), at three points, one in the center of the crown of the tooth, another in the center of the cervical region and the last one in the incisal region, with the light beam directed apically, from all teeth to the second premolar of each upper and lower hemi-arch, with energy of of 1 Joule per point for 10 seconds. and evaluate if it was able to reduce the sensitivity after home whitening with 22% carbamide peroxide. | Radiation: Laser of low frequncy<br>* Apply the laser at three points on each tooth.<br>* Other names: Therapy EC, DMC;|
| Placebo Comparator: Associate the CPP-ACPF paste with the LASER<br>Associate the CPP-ACPF paste with the LASER, following the same clinical protocol mentioned above and assess whether the association is more efficient than both treatments alone. | Radiation: Laser of low frequncy<br>* Apply the laser at three points on each tooth.<br>* Other names: Therapy EC, DMC;Drug: CPP-ACPF<br>* Apply MI paste plus for five minutes, in the vestibular surface os teeth. During this time patientes should be with closed mounth ad should not talk or to split.<br>* Other names: MI paste plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity assessment | Aplly Repeated Measures ANOVA to analyze tooth sensitivity data reported by patients | Afeter 21 days of tooth whitening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensitivity, Tooth, Laser, Tooth Bleaching, Dentin Desensitizing Agents