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

Primary Purpose

Sensitivity, Tooth

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser of low frequncy
CPP-ACPF
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensitivity, Tooth focused on measuring Sensitivity, Tooth, Laser, Tooth Bleaching, Dentin Desensitizing Agents

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Maria Eduarda CardosoRecruiting
  • Federal University of Pará

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

No Intervention

Placebo Comparator

Placebo Comparator

Arm Label

CPP-ACPF PASTE APLICATION

Evaluate the effectiviness at home bleaching

LASER APLICATION

Associate the CPP-ACPF paste with the LASER

Arm Description

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.

To evaluate the effectiveness of at-home bleaching with 22% carbamide peroxide, with the help of the VITA Easyshade 4.0 spectrophotometer

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.

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.

Outcomes

Primary Outcome Measures

Sensitivity assessment
Aplly Repeated Measures ANOVA to analyze tooth sensitivity data reported by patients

Secondary Outcome Measures

Full Information

First Posted
March 17, 2022
Last Updated
April 13, 2022
Sponsor
Universidade Federal do Para
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1. Study Identification

Unique Protocol Identification Number
NCT05298059
Brief Title
The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Anticipated)
Study Completion Date
April 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Para

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Tooth
Keywords
Sensitivity, Tooth, Laser, Tooth Bleaching, Dentin Desensitizing Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
This is a double-blind study, so that to blind study participants, all treatments were performed in exactly the same way. To simulate the CPP-ACPF paste, a paste without active ingredient was manipulated, but with the same color, texture and smell of the CPP-ACPF paste. To simulate the application of the laser, the operator performed the clinical procedure of applying the laser to three bridges of each tooth, but without activating it. The sound emitted by the laser at each point was simulated by a cell phone application. To blind the evaluator of the results, he only had access to the patient's name and sensitivity data, but he did not have access to the group to which the participant belonged.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPP-ACPF PASTE APLICATION
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Evaluate the effectiviness at home bleaching
Arm Type
No Intervention
Arm Description
To evaluate the effectiveness of at-home bleaching with 22% carbamide peroxide, with the help of the VITA Easyshade 4.0 spectrophotometer
Arm Title
LASER APLICATION
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Associate the CPP-ACPF paste with the LASER
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Laser of low frequncy
Other Intervention Name(s)
Therapy EC, DMC
Intervention Description
Apply the laser at three points on each tooth.
Intervention Type
Drug
Intervention Name(s)
CPP-ACPF
Other Intervention Name(s)
MI paste plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity assessment
Description
Aplly Repeated Measures ANOVA to analyze tooth sensitivity data reported by patients
Time Frame
Afeter 21 days of tooth whitening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecy M Silva, Phd
Phone
+5591991144905
Email
cecymsilva@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Eduarda OP CARDOSO, MD
Phone
+5591985137591
Email
duda.akino@hotmail.com
Facility Information:
Facility Name
Maria Eduarda Cardoso
City
Belém
State/Province
Pará
ZIP/Postal Code
66075-110
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Eduarda Cardoso, M.D
Phone
+55 91 985137591
Email
duda.akino@hotmail.com
Facility Name
Federal University of Pará
City
Belém
State/Province
PA
ZIP/Postal Code
66075-110
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecy M Silva, Phd
Phone
+5591991144905
Email
cecymsilva@gmail.com
First Name & Middle Initial & Last Name & Degree
MARIA OP CARDOSO, MD
Phone
+5591985137591
Email
duda.akino@hotmail.com
First Name & Middle Initial & Last Name & Degree
Brennda L De Paula, Msc

12. IPD Sharing Statement

Plan to Share IPD
No
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The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching

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