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Whitening effect of mouthrinse and its safety: clinical study

The efficacy and safety of a whitening mouthrinse: randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8svbbf
Enrollment
Unknown
Registered
2019-08-27
Start date
2019-03-25
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

Tooth discoloration

Interventions

Forty-five selected volunteers will use 3 bleaching treatments: one group will use custom trays with 10% carbamide peroxide bleaching gel (15 subjects)
the other group will use a whitening mouthrinse (15 subjects) and the third group will use a mouthrinse without bleaching agent (15 subjects). The tray treatment will be performed for 14 days for 2 ho
Procedure/surgery
E06.420.750

Sponsors

Instituto de Ciência e Tecnologia UNESP
Lead Sponsor
Instituto de Ciência e Tecnologia UNESP
Collaborator

Eligibility

Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 18 years old until 55 years old; good general health; abscence of gingival recession, clinical signs of noncarioues cervical lesions or active carie, periodontal disease, fluorosis or enamel deffects; do not use orthodontic devices or removable prothesis; present all the teeth; had not been submited to bleaching treatment previously; avaiability to return in appoitments; teeth color A2 or darker; good gingival condition - abscence of inflammation or irritation

Exclusion criteria

Exclusion criteria: Use of medicine for chronical disease or allergies; somokers; pregnant; participating in another study in the same time; presence of restorations on anterior teeth; use of products fluoride-based or dessensibilizing; tooth sensitivity; bruxism

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

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 potential demineralization by bleaching techniques among the groups. The potencial demineralization with enamel microbiopsis;Expected Secondary Outcome 4: 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 based on OIDP

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)