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

At-home bleaching using prefilled whitening trays compared with fabricated trays: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6jkg8s
Enrollment
Unknown
Registered
2018-04-13
Start date
2017-03-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mottled teeth

Interventions

Before the treatmente begining, the volunteers will be submitted to promice profilaxys and tooth color will be registered in appropriate tab with Vitapan Classical and Vita Bleachedguide 3D-Master sca
gingival condition
potential enamel demineralization
and patient satisfaction will be evaluated. Tooth sensitivity will be evaluated with a numeric scale from 0 to 10: 0 corresponding no sensitivity and 10 the worst possible pain. The volunteers should
E06.420.750

Sponsors

Instituto de Ciência e Tecnologia, Universidade Estadual Paulista "Julio de Mesquita Filho"
Lead Sponsor
Instituto de Ciência e Tecnologia, Universidade Estadual Paulista "Julio de Mesquita Filho"
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
Expected Secondary Outcome 1: There will be no difference in tooth sensibility reported among the groups. Tooth sensibility determined by visual analogue scale;Expected Secondary Outcome 2:There will be no difference in gingival condition reported among the groups. Gingival condition determined by Loe index;Expected Secondary Outcome 3: There will be no difference in patient satisfaction for bleaching techniques among the groups. Patient satisfaction with a subjective evaluation about bleaching procedures with a questionnaire;Secondary outcome found 1: There was difference in tooth sensibility among the groups (p value lower than 0.05). In risk absolute determination, the groups was similiar among them (p value higher than 0.05). Considering tooth sensibility intensity, comparing the groups, there were no difference for the time and interaction factors, but there was difference for bleaching factor, in which, OGO presented higher tooth sensibility intensity than WTC (p value higher than 0.05);Secondary outcome found 2:There was difference in gingival condition verified (valor de p lower than 0.05). For absolute risk, there was difference among the groups (valor de p lower than 0.05). OGO presented higher gingival inflamation than WTC and OPF didi not presented gingival inflamation. For intensity, it was similar among the groups after the end of the treatment;Secondary outcome found 3:There was no difference in volunteers satisfaction in relation to the result of bleaching technique. More than 85% of patients were satisfied;Expected Secondary Outcome 4: There will be no difference in enamel demineralization for bleaching techniques among the groups. Enamel demineralization will be assessed by diode laser device.;Secondary outcome found 4: No signal of enamel demineralization was found among the groups after treatment.

Countries

Brazil

Contacts

Public ContactAlessandra Borges

Instituto de Ciência e Tecnolgia

alessandra@fosjc.unesp.br55(12)39479000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)