Clinical evaluation of in-office Bleaching Agents

Not Applicable

Conditions: Bleaching Agents
C07.793.735

Registration Number: RBR-10cg75rw

Lead Sponsor: niversidade Federal de Santa Maria

Brief Summary: In recent years, manufacturers have introduced different whitening products to the market in various forms of presentations and concentrations, with the aim of improving the whitening outcome. Research on the effectiveness of the 37% Carbamide Peroxide bleaching agent is limited, with only a few laboratory studies and clinical trials conducted. Through a double-blind randomized clinical trial, this study aimed to determine the effectiveness of two whitening products (Hydrogen Peroxide 35% and Carbamide Peroxide 37%) for in-office use. Volunteers were examined to assess whether they could participate in the research, using the inclusion and exclusion criteria. Subsequently, randomization was carried out to define the distribution of groups according to the bleaching agent to be applied. Study operator was blinded to the type of whitening treatment until the envelopes were opened. The evaluator was trained in color measurement procedures. In the first whitening session (T0 – Baseline), the initial color was assessed prior to the application of the bleaching agent. The protocols were carried out according to the manufacturers' instructions. The bleaching agents were applied in 3 sessions (T0, T1 and T2) with an interval of 7 days among them. In Group 1 (G1), a 35% Hydrogen Peroxide bleaching agent was used. In Group 2 (G2), a 37% Carbamide Peroxide bleaching agent was used. The objective analysis was carried out with a clinical spectrophotometer, the CIEL*a*b* color coordinates were measured three times in the middle third of the buccal surface of upper right central incisor of each patient, using the previously prepared positioning guide. The whiteness index for dentistry (WID), the CIEDE 2000 color difference (?E00) and the whiteness difference (?WID) between T0 and each evaluation period were calculated. At the end of treatment, the mean values of L*, a*, b* and WID for the group treated with 37% carbamide peroxide were: L*= 89.12 (4.063), a*=-2.00 (0.689), b*= 19.1 (2.07) and WID= 29.0 (3.96). At the end of treatment, the mean values of L*, a*, b* and WID for the group treated with 35% hydrogen peroxide were: L*= 89.75 (3.23), a*=-2.35 (1.00), b*= 16.6 (3.16) and WID= 33.5 (4.87). There was no statistically significant difference between the groups for the mean values of L* (p=0.769) and a* (p=0.231). However, the mean values of b* (p <.001) and WID (p <.001) showed statistically significant differences between the groups, with hydrogen peroxide presenting more favorable whitening-related outcomes. The mean values of color difference (deltaE 2000) and whiteness difference (deltaWID) were interpreted based on the acceptability and perceptibility thresholds and their respective ratings. At the end of the treatment, it was observed that the group treated with hydrogen peroxide showed excellent effectiveness with mean values above ?E00 > 5.4 and ?WID > 7.8 and, the group treated with 37% carbamide peroxide, showed very good whitening effectiveness with mean values between 3.6 < ?E00=5.4 and 5.2 < ?WID = 7.8. Both protocols were able to promote tooth whitening, with 35% hydrogen peroxide showing excellent effectiveness and carbamide peroxide showing very good effectiveness. Hydrogen peroxide was able to produce greater whiteness (WID) and a greater reduction in the yellowness of the teeth (b*).

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruitment completed

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

Have at least 24 teeth in the mouth. Be interested and available for treatment. Good periodontal health, without the need for interventions. Good general health. Dental elements color A3 or darker according to the Vita Classical shade guide. Caries-free teeth.Teeth without restorative needs

Exclusion Criteria

Patients who refuse to participate in the treatment. Pregnant women. Nursing mothers. Smokers. Patients with bruxism or another condition that causes gingival recession and/or dentine exposure. Patients who have already undergone dental bleaching. Patients who report spontaneous sensitivity and/or sensitivity generated by cold drinks and foods. Patients undergoing orthodontic treatment. Patients undergoing periodontal treatment. Patients with ISG >30% of the areas/sites involved. Patients with IPV >30% of the areas/sites involved. Anterior teeth with restoration on the buccal surface. Anterior teeth with veneers or crowns.Teeth with internal staining (tetracycline, fluorosis or endodontic treatment). Endodontically treated anterior teeth.· Patients being treated with anti-inflammatories and/or analgésico