Combined Bleaching Technique: Efficacy and Tooth Sensitivity

Terezinha de Jesus Esteves Barata

Status and phase: Completed; Phase 4

Conditions: Tooth Sensitivity; Tooth Bleaching

Treatments: Procedure: Combined Bleaching (1x20); Procedure: Combined Bleaching(2x20) with arginine; Procedure: Combined Bleaching(2x20); Procedure: Combined Bleaching(1x20) with arginine; Drug: 8% arginine and calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT03089216

043178

Details and patient eligibility

About

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%).

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 4 patient groups

Combined Bleaching(2x20)

Experimental group

Description:

In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide

Treatment:

Procedure: Combined Bleaching(2x20)

Combined Bleaching(2x20) with arginine

Experimental group

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.

Treatment:

Drug: 8% arginine and calcium carbonate

Procedure: Combined Bleaching(2x20) with arginine

Combined Bleaching(1x20)

Experimental group

Description:

In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide

Treatment:

Procedure: Combined Bleaching (1x20)

Combined Bleaching(1x20) with arginine

Experimental group

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.

Treatment:

Drug: 8% arginine and calcium carbonate

Procedure: Combined Bleaching(1x20) with arginine