Back to resultsCombined Bleaching Technique: Efficacy and Tooth Sensitivity
Primary Purpose
Tooth Bleaching, Tooth Sensitivity
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Combined Bleaching(2x20)
Combined Bleaching(2x20) with arginine
Combined Bleaching (1x20)
Combined Bleaching(1x20) with arginine
8% arginine and calcium carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Bleaching
Eligibility Criteria
Inclusion Criteria:
- Upper and lower anterior teeth without restorations;
- Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
Exclusion Criteria:
- Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
- Presence of non-carious lesions, such as abfraction, erosion and abrasion;
- Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
- Use of fixed orthodontic appliances;
- Presence of tooth sensitivity classified as equal to or greater than mild;
- Presence of severe dental dimming;
- Presence of parafunctional habits;
- Presence of any oral pathology;
- Smokers;
- pregnant and lactating women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Combined Bleaching(2x20)
Combined Bleaching(2x20) with arginine
Combined Bleaching(1x20)
Combined Bleaching(1x20) with arginine
Arm Description
In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
Outcomes
Primary Outcome Measures
Tooth Sensitivity (TS)
Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)).
Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median.
Secondary Outcome Measures
Color Evaluation
Objective color evaluation:
The shade was determined using spectrophotometer VITA Easyshade, in which the parameters L*, a*, and b*, in which L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis.
The color alteration (ΔE) was determined by the differences between the values obtained at baseline and one month after the treatment, which was calculated with the formula: ΔE = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2]1/2.
In the Outcome Measure Data Table it was presented Mean and Standard Deviation of the color alteration (ΔE) between Baseline vs one month after bleaching for each group.
Full Information
NCT ID
NCT03089216
First Posted
March 17, 2017
Last Updated
June 19, 2019
Sponsor
Terezinha de Jesus Esteves Barata
1. Study Identification
Unique Protocol Identification Number
NCT03089216
Brief Title
Combined Bleaching Technique: Efficacy and Tooth Sensitivity
Official Title
Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Terezinha de Jesus Esteves Barata
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).
Detailed Description
This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .
After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Bleaching, Tooth Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combined Bleaching(2x20)
Arm Type
Experimental
Arm Description
In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
Arm Title
Combined Bleaching(2x20) with arginine
Arm Type
Experimental
Arm Description
Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
Arm Title
Combined Bleaching(1x20)
Arm Type
Experimental
Arm Description
In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide
Arm Title
Combined Bleaching(1x20) with arginine
Arm Type
Experimental
Arm Description
Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.
Intervention Type
Procedure
Intervention Name(s)
Combined Bleaching(2x20)
Intervention Description
one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Intervention Type
Procedure
Intervention Name(s)
Combined Bleaching(2x20) with arginine
Intervention Description
one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Intervention Type
Procedure
Intervention Name(s)
Combined Bleaching (1x20)
Intervention Description
one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Intervention Type
Procedure
Intervention Name(s)
Combined Bleaching(1x20) with arginine
Intervention Description
one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Intervention Type
Drug
Intervention Name(s)
8% arginine and calcium carbonate
Other Intervention Name(s)
dentifrice containing carbonate arginine
Intervention Description
using during all the treatment.
Primary Outcome Measure Information:
Title
Tooth Sensitivity (TS)
Description
Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)).
Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median.
Time Frame
during bleaching, and up to 48 hours postbleaching
Secondary Outcome Measure Information:
Title
Color Evaluation
Description
Objective color evaluation:
The shade was determined using spectrophotometer VITA Easyshade, in which the parameters L*, a*, and b*, in which L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis.
The color alteration (ΔE) was determined by the differences between the values obtained at baseline and one month after the treatment, which was calculated with the formula: ΔE = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2]1/2.
In the Outcome Measure Data Table it was presented Mean and Standard Deviation of the color alteration (ΔE) between Baseline vs one month after bleaching for each group.
Time Frame
The evaluations were performed in the baseline period and one month after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Upper and lower anterior teeth without restorations;
Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
Exclusion Criteria:
Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
Presence of non-carious lesions, such as abfraction, erosion and abrasion;
Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
Use of fixed orthodontic appliances;
Presence of tooth sensitivity classified as equal to or greater than mild;
Presence of severe dental dimming;
Presence of parafunctional habits;
Presence of any oral pathology;
Smokers;
pregnant and lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella N Favarão, DDS, MS
Organizational Affiliation
Universidade Federal de Goias
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Bleaching Technique: Efficacy and Tooth Sensitivity
We'll reach out to this number within 24 hrs