At-home bleaching using prefilled whitening trays compared with fabricated trays

Not Applicable

• Conditions: Mottled teeth; Z00-Z99

• Registration Number: RBR-6jkg8s
• Lead Sponsor: Instituto de Ciência e Tecnologia, Universidade Estadual Paulista Julio de Mesquita Filho

Brief Summary

Objective: To compare at-home systems outcomes using 10% hydrogen peroxide (HP) gel with prefilled or customized trays for 30 min/daily, and 10% carbamide peroxide (CP) gel for 2h/daily, with the conventional nightguard vital bleaching (10%CP). Bleaching efficacy, tooth sensitivity, gingival condition, enamel demineralization and patient’s satisfaction were evaluated. Methods: Sixty participants were randomly divided into treatments (1x/day-14d): OGO (Opalescence GO- 10%HP prefilled tray- 30min); WTC (White Class- 10%HP customized tray- 30min); OPF2 (Opalescence PF- 10%CP- 2h), and OPF8 (Opalescence PF- 10%CP- 8h). Color change, tooth sensitivity, gingival condition, enamel demineralization, and patients’ satisfaction were assessed. Statistical tests were applied (5%). Results: The color change was similar for the groups (p>0.05) and maintained after one year. All groups showed some TS risk, with no differences among them (p>0.05). The intensity of sensitivity and gingival irritation was mild for all gels, but higher for OGO. All participants were satisfied with treatments. Conclusions: All systems produced similar bleaching efficacy, which was maintained after one year. Patients were satisfied with bleaching outcomes. Tooth sensitivity occurred in all groups, but with overall mild intensity. Mild gingival irritation was observed with HP and OPF8 groups. No relevant demineralization effect was detected.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-13
• Study Completion: 2018-11-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Ages from 18 until 30 years old; good general health; do not present enamel erosion, dental abfraction, caries, periodontal disease or fluorosis ; do not use orthodontic appliance or removable prostheses; present all teeth - first molar to first molar (Upper and Lower); Avaiability of recurring returns; absence of gingival recession; teeth with A2 or darker color.

Exclusion Criteria

Chemically dependent patients, nonsmokers and alcoholic ; medical condition that may interefere in patients' security during the study: use of drug therapy to chronic disease or allergic reaction to substances that will be used; pregnancy; participate of another study in the same time; pressenting restorations in the six anterior teeth of each arch; frequent use of fluoride supplementation or desensitization substances; bruxism; periapical lesions; tooth sensitivity.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
There will be no difference in tooth color change among the groups. Color change determined by visual scales Vitapan Classical and Bleachedguide 3-D Master and spectrophotometer Easyshade;There was no difference in tooth color change among the groups verified with visual scales Vitapan Classical and Bleachedguide 3-D Master and spectrophotometer Easyshade (p value higher than 0.05)