Combined Bleaching Technique: Efficacy and Tooth Sensitivity

Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial

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%).

Study Overview

• Status: Completed
• Conditions: Tooth Bleaching; Tooth Sensitivity
• Intervention / Treatment: Procedure: Combined Bleaching(2x20); Procedure: Combined Bleaching(2x20) with arginine; Drug: 8% arginine and calcium carbonate; Procedure: Combined Bleaching (1x20); Procedure: Combined Bleaching(1x20) with arginine

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Combined Bleaching(2x20); In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide	Procedure: Combined Bleaching(2x20); 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.
EXPERIMENTAL: Combined Bleaching(2x20) with arginine; 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.	Procedure: Combined Bleaching(2x20) with arginine; 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.; Drug: 8% arginine and calcium carbonate; using during all the treatment.; Other Names: dentifrice containing carbonate arginine
EXPERIMENTAL: Combined Bleaching(1x20); In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide	Procedure: Combined Bleaching (1x20); 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.
EXPERIMENTAL: Combined Bleaching(1x20) with arginine; 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.	Drug: 8% arginine and calcium carbonate; using during all the treatment.; Other Names: dentifrice containing carbonate arginine; Procedure: Combined Bleaching(1x20) with arginine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during bleaching, and up to 48 hours postbleaching

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The evaluations were performed in the baseline period and one month after the treatment

Collaborators and Investigators

• Sponsor: Terezinha de Jesus Esteves Barata
• Investigators: Principal Investigator: Isabella N Favarão, DDS, MS, Universidade Federal de Goias

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): November 30, 2016
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: 043178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No